Webinar: “What to Know about Complementary Medicine for Parkinson’s” May...

From Michael J. Fox Foundation.

A New Attack on Parkinson’s Disease

One promising approach could also help with other neurodegenerative disorders, including Alzheimer’s and Huntington’s disease.

By JON PALFREMAN

Oct. 2, 2015  

Walking in the east London neighborhood of Shoreditch in the early 1800s, the physician James Parkinson noticed certain individuals who moved differently from the crowd. In 1817 he articulated their symptoms, such as tremor, rigidity, slow movements and stooped gait. His “Essay on the Shaking Palsy” became the first description of what is now called Parkinson’s disease. Toward the end of this classic document, Parkinson remarked in passing, “there appears to be sufficient reason for hoping that some remedial process may ere long be discovered, by which, at least, the progress of the disease may be stopped.” 

Some 200 years later, the disease, which affects one million Americans and seven million people world-wide, still hasn’t been cured. While drugs such as L-dopa and surgeries such as deep brain stimulation can help manage the symptoms, all attempts to slow, stop or reverse the disease’s course have failed. Efforts to protect dopamine cells with drugs, to revive dopamine cells with special growth factors and, most controversially, to graft new dopamine-making cells derived from fetal tissue into the brains of Parkinson’s patients, have not panned out. 

Yet recent developments have given patients like myself hope that we may be on the verge of a breakthrough that could stop the disease as James Parkinson predicted.

ENLARGE

The first page of James Parkinson's 1817 work, ‘An Essay on the Shaking Palsy.’

Many researchers think that the bad actor in Parkinson’s disease is a simple protein, called alpha-synuclein, gone rogue. The misfolded molecule forms sticky clumps called amyloids that jump from neuron to neuron killing cells. They in particular snuff out the nerve cells that make a crucial brain chemical, the neurotransmitter dopamine. 

The modern picture of Parkinson’s disease resembles a play in three acts. First, the alpha-synuclein-driven disease process starts, possibly in the nose or the gut, as much as 10 or 20 years before a person is diagnosed with Parkinson’s. While there is not yet a definitive way to detect such early pathology, epidemiological studies show that certain symptoms—constipation, loss of smell and sleep disorders, for example—are associated with an increase in the odds of developing Parkinson’s disease later. 

In act two, the alpha-synuclein moves on to the mid-brain and kills off dopamine cells in a region called the substantia nigra. When 70% of these dopamine cells are destroyed, the patient starts displaying the classic tremors and other symptoms of Parkinson’s disease. 

In act three, the disease migrates to other brain areas such as the cerebral cortex, where it can cause hallucinations, cognitive impairment and dementia.

If alpha-synuclein is the protagonist in this story, then, reducing its levels in the brain should help control the disease. That’s what researchers have been working on. A number of alpha-synuclein-busting agents are due to begin clinical trials in the next year or two. One product, developed by NeuroPhage in Cambridge, Mass., is based on a simple virus called M13. This product may be able to reduce the amounts of not only alpha-synuclein, but also the equivalent amyloids of other neurodegenerative diseases, including Alzheimer’s and Huntington’s disease.

Should this type of treatment work, the possibilities are extraordinary. If given early enough, such agents might prevent the development of the classic and disabling symptoms of Parkinson’s disease from ever materializing. And for patients like me who already have the disease, such interventions might stop the disease in its tracks, enabling such patients to maintain our current level of health and avoid developing cognitive impairment and dementia.

Having studied the past 200 years of Parkinson’s research, I am fully aware that this strategy may not succeed. Biomedical research is largely a story of failure. But from each setback comes knowledge that leads to new hypotheses. Sooner or later, we will vanquish this pernicious malady. I just hope that I’ll be around to see it.

Mr. Palfreman is the author of “Brain Storms: The Race to Unlock the Mysteries of Parkinson's disease,” published this month by Scientific American/Farrar, Straus & Giroux.

http://www.wsj.com/articles/a-new-attack-on-parkinsons-disease-1443827360

Parkinson's Patient Walking Again

By Megan Allison/KTVL.com

Oct. 1, 2015
Medford --

Kevin Tucker was diagnosed with Parkinson's in 2014. At 46 year's old he's a young patient for the disease.

"I never thought I'd be...have Parkinson's. I mean it's...it's a bit of a shock to have," Tucker said.

Tucker first believed he had Parkinson's when he had trouble walking. He often tries to walk around his neighborhood with his two daughters.

"Parkinson's...what it was doing to me was making it hard to walk. Like I would have a limp, dragging my leg," Tucker said.

But he said the disease was not easy to diagnose.

"It took a long time to get a neurologist who understood what was happening to me. I'd go to three or four different neurologists who said what's wrong? And nobody got it until this last guy," Tucker said.

His most recent neurologist recommended he undergo deep-brain stimulation. This involves delivering a shock to select brain regions. Tucker underwent surgery in April of this year at the Barrow Neurological Institute in Phoenix. He said he had nothing to lose.

"The disease is progressive so you're going to need more and more and more and more as time goes on. I'm fairly young for being diagnosed with this disease. It's more of a 60/70-year-old kind of disease," Tucker said.

He takes medication to keep him walking. He said the surgery helped make the medicine more effective.

"They tide the medicine down and work the stimulation up to try and keep it...you only want to try and move one variable at a time," Tucker said.

He hopes the procedure will prevent the need for increased medication over time. He said his daughters have noticed on their walks that he's moving easier.

http://health.einnews.com/article/289432024/PtMj5ZLnR3sweoEO

Study: Pesticide Exposure Raises Parkinson's Rates Near Gaza Area Farms

The percentage of Parkinson’s sufferers in these farming communities is 37-54 percent higher than the average in the Negev.

Thai workers tending a farm in Israel. Eliyahu Hershkovitz

An Israeli study has found a high incidence of Parkinson’s disease among those living in Jewish agricultural communities near the Gaza border.

According to the study, the percentage of Parkinson’s sufferers is 37 percent to 54 percent higher than the average in the Negev. The researchers, neurologists from the Soroka Medical Center in Be’er Sheva, believe that the reason for the high morbidity is exposure to pesticides, which are used in the cultivated fields.

Parkinson’s is a gradual degenerative disease that affects the central nervous system, and is characterized by motor disturbances such as a slowing and decline in movement, muscle rigidity, involuntary tremors, problems of balance and more. The source of the illness is defective functioning in the parts of the brain responsible for motor control. There is no certainty about the causes, but the prevailing assumption is that they are genetic as well as environmental.

This is not the first time that a connection has been made between exposure to pesticides and a higher incidence of Parkinson’s.

“Our study joins studies that reinforce the environmental connection to Parkinson’s, and we believe there’s a connection between agricultural pesticides and the disease,” says Dr. Yair Zlotnik of the Soroka neurology department, one of the researchers.

The present study uses the database of Parkinson’s patients in the area of the Gaza envelope who are insured by Clalit Health Services (which insures 70 percent of the Negev population), and included 3,792 patients, Jews and Bedouin, some living in cities or communal settlements and some in agricultural communities and in the Bedouin diaspora. The information was examined relative to the proximity of the patients to cultivated fields in their area of residence.

There were dramatic differences in the frequency of the disease – among Jews the percentage of Parkinson’s sufferers is 37 percent higher than the average in the Negev in places with few cultivated fields. In communities with many cultivated fields the morbidity is 54 percent higher than the regional average. In the Bedouin diaspora the frequency is 53 percent lower than the average in the Negev as a whole, and 71 percent lower than the average in the permanent communities that are not surrounded by cultivated fields.

“The study enabled us to see clearly the differences between the genetic and environmental contribution,” explained Zlotnik. “We know that in the Ashkenazi Jewish population [originating in Europe] there are a number of genes that increase the risk of the disease, and morbidity among Ashkenazim is in fact higher in general. Among the Bedouin, who have no genetic tendency for the disease, we discovered that those living in the Bedouin diaspora near agricultural fields suffer more from Parkinson’s than those living in permanent communities.”

The study is actually a continuation of one conducted in Soroka in the late 1990s. At the time they examined three kibbutzim in the Gaza envelope area and found a high incidence. Due to improved technology and documentation since then the present study is more precise and more comprehensive.

But still the study has shortcomings – it doesn’t measure morbidity in connection with specific types of pesticides. “We assume that the morbidity that we’re seeing today is a result of degenerative processes that began 20-30 years ago, and it’s hard to know today exactly to which substances they were exposed,” says Zlotnik.

Nor did the researchers take into account the residential history of the patients in the area, or in other words, for how long they were exposed to the pesticides in the Gaza area. “There’s still a lot to study regarding this connection,” explains Zlotnik. “We think that there’s room for follow-up studies, maybe together with the Environmental Protection Ministry, in order to study the nature of the exposure and its effects in greater depth.”

http://health.einnews.com/article/289053059/Md-0sjTcSm9R473K

Potential breakthrough treatment for Parkinson's Disease - Story | 4State Area - Maryland, Pennsylvania, Virginia and West Virginia | Your4State | WHAG-TV

Potential breakthrough treatment for Parkinson's Disease - Story | 4State Area - Maryland, Pennsylvania, Virginia and West Virginia | Your4State | WHAG-

Potential breakthrough treatment for Parkinson's Disease

Patient from Frederick says the treatment turned back the clock for her

By Carolyn Blackburne | cblackburne@whag.com

Published 09/28 2015 09:26AM

Updated 09/30 2015 12:19PM

• 
• 

Sept. 29, 2015 FREDERICK, Md.

Doctors at the University of Maryland Medical Center said they may have found a breakthrough treatment for Parkinson’s disease patients. Doctors said it’s already turned back the clock for one Parkinson’s patient from Frederick.

Kimberly Spletter said her Parkinson’s disease stripped her of her mobility. She sometimes she couldn’t even walk.

“My husband was helping me cut my food up, just a month ago,” Spletter said.

Parkinson’s is a degenerative disease of the nervous system. Paul Fishman, a Neurologist at the University of Maryland Medical Center, said there is no cure for the disease, only an old treatment with its own set of side-effects.

“As time goes on, it’s not as effective. As the disease gets worse, it works erratically,” Fishman said.

But now, doctors are experimenting with a new treatment, that’s never been done before. It’s called MRI Guided Ultrasound. Howard Eisenberg, a neurologist at the University of Maryland Medical Center, said Spletter is put into an MRI machine so that doctors can get a close-up look at her brain’s activity. Then, ultrasound waves are targeted to the part of her brain that’s linked with the uncontrolled movements.

“The symptoms we’re trying to relieve are those symptoms like tremor, rigidity,” Eisenberg said.

Spletter said she underwent this treatment in August, and now, just one month later, she can walk. She can even ride her bike again.

“Anything I ever wanted to do, I can do again. I can ride my bike, I can run, I can walk, I can take my grandson to the park, I can do everything.

Spletter was the first person to undergo this treatment at the University of Maryland Medical Center, so Eisenberg and Fishman said they have no idea how long its effects will last. 

“I have a whole new life ahead of me again. I thought that everything that was holding me back, it’s not anymore. I can do anything I want now,” Spletter said.

Eisenberg and Fishman said there is still a very long road ahead of them before this treatment could become a mainstream solution for Parkinson’s patients. But they are hopeful, because it is incredibly rare for clinical trials like this to produce immediate results.

Because Spletter is the first and only patient to undergo this treatment, Eisenberg and Fishman said they will continue to check-up on her progress over the next few years. WHAG will be following her story to see how this groundbreaking treatment holds up.

Copyright 2015 Nexstar Broadcasting, Inc. All rights reserved. This material may not be published, broadcast, rewritten, or redistributed.

http://www.your4state.com/news/news/potential-breakthrough-treatment-for-parkinsons-disease#.Vgye2SXiYe0.blogger

With DBS for Parkinson's Disease, Implantation Sequence Matters

By Lorraine L. Janeczko

September 29, 2015

NEW YORK (Reuters Health) - When using a standard stereotactic technique for deep brain stimulation (DBS), the second brain lead implanted on the opposite side of the brain may not be placed as accurately as the first, according to research from Canada.

The order of electrode insertion during bilateral DBS may have a small impact on clinical outcomes due to increased electrode dispersion on the second implanted side, the study team reported online September 9 in the Journal of Neurology, Neurosurgery & Psychiatry.

"This study proves that the implantation of the second hemisphere is slightly less accurate than the first one," Dr. Alfonso Fasano of the Movement Disorders Center at Toronto Western Hospital told Reuters Health by email.

Dr. Fasano and colleagues analyzed clinical and radiographic data on 76 patients, aged 58 years on average, with Parkinson's disease. The participants underwent surgery at one academic medical center and completed at least one year of follow-up.

The researchers calculated electrode location dispersion as the square of the deviation from the population mean, and they analyzed the deviation direction by comparing the intended and final implantation coordinates. They analyzed the predictors of postoperative motor condition improvement by linear regression, controlling for electrode implantation sequence.

Compared with the first side, the second-side electrode tip had significantly higher dispersion as an overall effect (5.6 vs 2.2 mm2, p=0.04), or along the X-axis (4.1 vs 1.4 mm2, p=0.03) and the Z-axis (4.9 vs 2.9 mm2, p=0.02).

Second-side stimulation was associated with lower threshold for side effects (contact 0, p<0.001 and contact 3, p=0.004). In linear regression, baseline activities of daily living (p=0.010) and electrode dispersion on the second side (p=0.005) were significant outcome predictors.

"This large study, with rigorous documentation of lead location and implantation using the same procedure in all cases, confirms suspicions previously held in the movement disorders community," Dr. Kelly Mills, of the Parkinson's and Movement Disorders Center at Johns Hopkins in Baltimore, Maryland, told Reuters Health by email.

"The authors do a good job of proposing several explanations for lead location variability, including brain shift, pneumocephalus, ventricular enlargement, difficulty in X-ray visualization of the second electrode due to the presence of an existing electrode, and decreased cooperation by the patient as he or she fatigues during surgery," he said.

"It is important that this study was performed by an experienced DBS team, and that lead location variability might be even higher at less-experienced centers or when using other surgical techniques," added Dr. Mills, who was not involved in the study.

Dr. Alon Mogilner, director of the Center for Neuromodulation at New York University Langone Medical Center in New York City, told Reuters Health by phone, "Patients with Parkinson's disease undergoing DBS usually have Parkinson's on both sides of their body, so they need to have the surgery on both sides of their brain."

The left- and right-sided electrodes can be placed on the same day or a few days, weeks, or months apart, explained Dr. Mogilner, who was not involved in the study.

"The advantage of inserting electrodes on the same day is one less hospital stay for the patient, but the outcomes may not be as good," he cautioned.

One possibility to explain the study findings is that the brain actually moves, Dr. Mogilner told Reuters Health. "You drill a small hole in each side of the head, and all you can see are the two holes. You cannot see the brain moving, and between the time it takes you to insert the first and second electrodes, it may shift. A 'brain shift' of only a millimeter or so can be clinically significant."

Dr. Mogilner advised that surgeons implant the electrodes on different days or use intraoperative magnetic resonance imaging (MRI) scans to help them accurately place both electrodes on the same day.

"In the U.S., maybe 25% of centers now use intraoperative imaging," Dr. Mogilner said, but he predicts this technique to become more common over the next few years.

"The most important predictor of outcome after DBS is accurate location of the brain electrodes. Nothing substitutes for accurately placed electrodes," he said.

The authors reported no funding or conflicts of interest.

SOURCE: http://bit.ly/1iWYQDI

J Neurol Neurosurg Psychiatry 2015.

http://www.medscape.com/viewarticle/851743?src=wnl_edit_tpal

Antipsychotics increase Risk of Death in people with Parkinson's disease psychosis

Wednesday 30 September 2015 

Antipsychotic drugs may increase the risk of death in people with Parkinson's disease psychosis (PDP), according to a new study led by researchers from the Institute of Psychiatry, Psychology & Neuroscience (IoPPN) at King's College London.

The study, published in JAMDA, found that people with PDP who were treated with antipsychotics were four times more likely to have died following three to six months of treatment than those who did not receive any antipsychotic medication. They were also more likely to experience serious health issues including cognitive decline, worsening of Parkinson's symptoms, stroke, infections and falls.

Parkinson's disease affects approximately 7-10 million people worldwide and is characterised by progressive loss of motor function, psychiatric symptoms and cognitive impairment. Psychosis is a common and distressing group of psychiatric symptoms affecting people with Parkinson's, usually manifesting as hallucinations and delusions.

PDP affects more than 50 per cent of people with Parkinson's at some point in their condition and antipsychotic drugs are often used to treat this psychosis, yet there is little evidence to support their use.

The researchers examined more than 400 people with PDP, who were taking part in a separate trial, to assess the impact of antipsychotic medications on their overall health and wellbeing. Participants were categorised into two groups - those receiving antipsychotics and those who did not take any antipsychotic medications at any time during the study.

Professor Clive Ballard from the Wolfson Centre for Age-Related Diseases at the IoPPN, King's College London, said: 'Our findings clearly indicate serious risks associated with antipsychotics and highlight the need for greater caution in treating psychosis in Parkinson's disease.

'Antipsychotics are known to be linked to serious harm in people with Alzheimer's Disease, and these findings show that a similar, although not identical, risk is seen in people with Parkinson's. Our findings therefore strongly suggest that doctors, patients and family members should consider these risks very carefully when considering potential treatments for psychosis and any other behavioural symptom in people with Parkinson's Disease, such as agitation or aggression.

'Further research is required to develop new, better treatments for psychosis and other behavioural symptoms.'

Professor Ballard added: 'For example, a study we published last year showed that a novel antipsychotic, pimavanserin, was effective and had far fewer side effects than traditional antipsychotics.'

http://www.medicalnewstoday.com/releases/300306.php?tw

Understanding Parkinson's Disease: An Interview with Jon Palfreman

Award-winning journalist Jon Palfreman, author of Brain Storms: The Race to Unlock the Mysteries of Parkinson's Disease, discusses the science behind this mysterious disease

By Sabrina Stierwalt, PhD. | September 27, 2015

Scientific American presents Everyday Einstein by Quick & Dirty Tips. Scientific American and Quick & Dirty Tips are both Macmillan companies.

When award-winning science journalist Jon Palfreman investigated a group of drug addicts who mysteriously ended up with Parkinson's-like symptoms after a bad batch of heroin—the story that would end up launching his career—he never imagined that more than 25 years later he would be diagnosed with the disease himself. Today there are roughly 1 million Americans living with Parkinson’s and about 60,000 new cases each year. In this interview, Jon discusses his new book, Brain Storms: The Race to Unlock the Mysteries of Parkinson's Disease, detailing the scientific history of a search for a cure, as well as his own experience with Parkinson's.

Jon offers advice for translating the uncertainties that often come with medical advice and suggests how we can try to reconcile those odds with our need for concrete answers. He explains our best chances at beating Parkinson's, including approaches that attempt to modify the disease as well as those that work to treat the symptoms.

SEE ALSO:

• Health: Researchers Seek Cancer Clues from Pet Dogs | 
• Sustainability: How Modern Agriculture Can Save the Gorillas of Virunga | 
• Tech: Are We on the Cusp of War—in Space? | 
• The Sciences: The Mystery of the Cat's Inner Eyelid

He also offers three suggestions on how those living with Parkinson's, as well as their family and friends, can understand such a complex disease and thus offer the best support:

1) Embrace your fellow patients who share your diagnosis for they are your new tribe. Connect with the Parkinson's community because you will find inspiration there. Jon tells the stories of a British surveyor who walked the coastline of Great Britain to raise money for Parkinson's research and of a New York ballet dancer who teaches dance classes for Parkinson's patients.When award-winning science journalist Jon Palfreman investigated a group of drug addicts who mysteriously ended up with Parkinson's-like symptoms after a bad batch of heroin—the story that would end up launching his career—he never imagined that more than 25 years later he would be diagnosed with the disease himself. Today there are roughly 1 million Americans living with Parkinson’s and about 60,000 new cases each year. In this interview, Jon discusses his new book, Brain Storms: The Race to Unlock the Mysteries of Parkinson's Disease, detailing the scientific history of a search for a cure, as well as his own experience with Parkinson's.

"Biomedical research sits at the intersection of truth and hope. Patients and biomedical researchers have to have hope that sometime in the future, things will get better."        - Jon Palfreman

Jon offers advice for translating the uncertainties that often come with medical advice and suggests how we can try to reconcile those odds with our need for concrete answers. He explains our best chances at beating Parkinson's, including approaches that attempt to modify the disease as well as those that work to treat the symptoms.

He also offers three suggestions on how those living with Parkinson's, as well as their family and friends, can understand such a complex disease and thus offer the best support:

1) Embrace your fellow patients who share your diagnosis for they are your new tribe. Connect with the Parkinson's community because you will find inspiration there. Jon tells the stories of a British surveyor who walked the coastline of Great Britain to raise money for Parkinson's research and of a New York ballet dancer who teaches dance classes for Parkinson's patients.

2) Exercise, exercise, exercise. For people with Parkinson's disease keeping mobile is not only important for staying positive but also likely staves off cognitive impairment.

3) Pay close attention to your own body and don't ignore it. You know yourself best and are with your body every day while your doctor may see you only once every 4-6 months.

Have you ever had to deal with a difficult diagnosis? How did you become empowered as a patient? You can weigh on my Facebook page, or follow me on Twitter, where I’m @QDTeinstein. If you have a question that you’d like to see on a future episode, send me an email at everydayeinstein@quickanddirtytips.com.

---

Jon Palfreman, PhD, is a professor emeritus of journalism at the University of Oregon. He is an Emmy, duPont, and Peabody Award-winning journalist, a Nieman Fellow, and the recipient of the Victor Cohn Prize for Excellence in Medical Science Reporting. In addition to producing more than forty primetime documentaries for the BBC and PBS, Palfreman is a coauthor of The Case of the Frozen Addicts and The Dream Machine. He lives in Lexington, Massachusetts.

Brain Storms, The Race to Unlock the Mysteries of Parkinson's Disease, is available now from Amazon, Barnes & Noble, Books-A-Million, Indiebound, and Apple.

- See more at: http://www.quickanddirtytips.com/education/science/understanding-parkinsons-disease-an-interview-with-jon-palfreman#sthash.WBoloVq1.dpuf

http://health.einnews.com/article/288542636/MbWvCw1vMyJQ9iTx

Raising Awareness of Parkinson's Disease

Posted: Sun 5:41 PM, Sep 27, 2015

Loss of smell, trouble sleeping, constipation, and shaking...Those are all signs of Parkinson's Disease. 

Well September is Parkinson's Awareness Month. Those from First Settlement Physical Therapy teamed up with a local Parkinson's support group to conduct a one-day awareness event.

Community members who attended could receive information on the disease along with participating in various exercises to test their motor skills. 

"Parkinson's is a really interesting disease as the people who have it have it for a prolonged period of time. So they are able to find support systems throughout their local areas and it's very helpful for them," said Amanda Schell, a Physical Therapist from First Settlement Physical Therapy.

One local man runs a support group for those with Parkinson's and to educate others about the disease. "We know the importance of movement. We are walking the side walks and just taking whatever pace we, is comfortable for us and the distance that's comfortable for each of our people," said Larry Ice who attended the event Sunday.

If anyone is interested in joining the local support group for Parkinson's Disease, they meet the second Saturday of each month at the Vienna library. 

http://health.einnews.com/article/288593463/hfq2ajR4JLgoasSj

Impax Receives Positive CHMP Opinion for NUMIENT™ (Levodopa and Carbidopa) Modified-Release Capsules for the Symptomatic Treatment of Adult Patients with Parkinson's disease

PR Newswire

AMSTERDAM, Sept. 25, 2015

AMSTERDAM, Sept. 25, 2015 /PRNewswire/ -- Impax Laboratories, Inc. (NASDAQ: IPXL) today announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency has adopted a positive opinion recommending that NUMIENT (IPX066), a modified-release oral capsule formulation of levodopa-carbidopa, be granted approval for the symptomatic treatment of adult patients with Parkinson's disease. The European Commission (EC) will now consider the CHMP positive opinion in its decision of whether to grant marketing authorization for NUMIENT in Europe. The review of this application is being conducted under the centralized licensing procedure as a therapeutic innovation, and the final decision will be applicable in all 28 member states of the European Union, as well as Iceland, Liechtenstein and Norway.

"The positive opinion from the CHMP recommending the approval of NUMIENT is a significant step forward to providing a new treatment option to patients in Europe suffering from Parkinson's disease," said Fred Wilkinson, President and Chief Executive Officer of Impax. "We are committed to realizing the full potential of this important franchise and we look forward to the European Commission's decision in the coming months."

"We continue to have discussions with potential partners to help commercialize NUMIENT in Europe. If approved, we will work quickly to bring NUMIENT to patients," concluded Mr. Wilkinson.

The CHMP's positive opinion is based on results from three Phase 3 controlled clinical studies which assessed the safety and efficacy of NUMIENT in patients with early (levodopa-naive) and advanced Parkinson's disease in the U.S. and in Europe. Refer to the "Summary of the Three Phase 3 Controlled Clinical Studies" for additional information.

About Parkinson's disease

Parkinson's disease is a chronic neurodegenerative movement disorder affecting approximately 7 to 10 million people globally[1]. There is currently no known cure for Parkinson's disease.

About NUMIENT

If approved in Europe, NUMIENT will be indicated for the symptomatic treatment of adult patients with Parkinson's disease. NUMIENT is not for use in patients with hypersensitivity to the active drug substances or excipients in NUMIENT, narrow-angle glaucoma, phaeochromocytoma, a previous history of neuroleptic malignant syndrome (NMS) and/or non-traumatic rhabdomyolysis, or in patients using nonselective monoamine oxidase inhibitors (MAO) inhibitors, which must be discontinued 2 weeks prior to starting to use NUMIENT.

Summary of the Three Phase 3 Controlled Clinical Studies

In APEX-PD, a trial that enrolled and randomized 381 levodopa-naive patients, the study met its primary efficacy endpoint of mean change from baseline in the sum of Unified Parkinson's Disease Rating Scale (UPDRS) Part II (activities of daily living) score and UPDRS Part III (motor examination) score for NUMIENT versus placebo at end of study.

In ADVANCE-PD, a trial of 393 randomized patients with advanced Parkinson's disease having "off" time, the results showed treatment with IPX066 (NUMIENT) reduced the percentage of "off" time (36.9% to 23.8%) from baseline versus immediate-release levodopa-carbidopa (36.0% to 29.8%) during waking hours to end of study, representing almost 1.2 hours of additional "off" time improvement. IPX066 (NUMIENT) also increased "on" time without troublesome dyskinesia during waking hours by 1.9 hours compared with an increase of 0.8 hours following treatment with immediate-release levodopa-carbidopa. Less "off" time was primarily related to more "on" time without troublesome dyskinesia.

In ASCEND-PD, a trial of 91 randomized patients with advanced Parkinson's disease having "off" time, compared IPX066 versus levodopa-carbidopa plus entacapone (LCE). Patients entered the study with a baseline "off" time of 36.1% (5.9 hours), and at the end of the randomized IPX066 treatment phase, patients had "off" time of 24.0% (3.8 hours) during waking hours compared to 32.5% (5.2 hours) for LCE (p<0.0001), representing 1.4 hours of additional "off" time improvement.

Summary of the NUMIENT Safety Profile

The most frequently reported adverse reactions in the 978 patients exposed to NUMIENT during the entire clinical program were nausea, occurring in approximately 12% of all patients; dizziness, headache, and dyskinesia, each occurring in approximately 8% of all patients; and insomnia, occurring in approximately 6% of all patients. Serious events of gastrointestinal haemorrhage (uncommon) and of allergic oedema (uncommon) were reported in the clinical studies with NUMIENT.

About Impax Laboratories, Inc.

Impax Laboratories, Inc. (Impax) is a specialty pharmaceutical company applying its formulation expertise and drug delivery technology to the development of controlled-release and specialty generics in addition to the development of central nervous system disorder branded products. Impax markets its generic products through its Impax Generics division and markets its branded products through its Impax Specialty Pharma division. Additionally, where strategically appropriate, Impax develops marketing partnerships to fully leverage its technology platforms and pursues partnership opportunities that offer alternative dosage form technologies, such as injectables, nasal sprays, inhalers, patches, creams and ointments. For more information, please visit the Company's Web site at: www.impaxlabs.com.

"Safe Harbor" statement under the Private Securities Litigation Reform Act of 1995:

To the extent any statements made in this news release contain information that is not historical; these statements are forward-looking in nature and express the beliefs and expectations of management. Such statements are based on current expectations and involve a number of known and unknown risks and uncertainties that could cause the Company's future results, performance, or achievements to differ significantly from the results, performance, or achievements expressed or implied by such forward-looking statements. Such risks and uncertainties include, but are not limited to: fluctuations in revenues and operating income; the Company's ability to successfully develop and commercialize pharmaceutical products in a timely manner; reductions or loss of business with any significant customer; the substantial portion of the Company's total revenues derived from sales of a limited number of products; the impact of consolidation of the Company's customer base; the impact of competition; the Company's ability to sustain profitability and positive cash flows; any delays or unanticipated expenses in connection with the operation of the Company's manufacturing facilities; the effect of foreign economic, political, legal, and other risks on the Company's operations abroad; the uncertainty of patent litigation and other legal proceedings; the increased government scrutiny on the Company's agreements with brand pharmaceutical companies; product development risks and the difficulty of predicting FDA filings and approvals; consumer acceptance and demand for new pharmaceutical products; the impact of market perceptions of the Company and the safety and quality of the Company's products; the Company's determinations to discontinue the manufacture and distribution of certain products; the Company's ability to achieve returns on its investments in research and development activities; changes to FDA approval requirements ; the Company's ability to successfully conduct clinical trials; the Company's reliance on third parties to conduct clinical trials and testing; the Company's lack of a license partner for commercialization of IPX066 outside of the United States; impact of illegal distribution and sale by third parties of counterfeits or stolen products; the availability of raw materials and impact of interruptions in the Company's supply chain; the Company's policies regarding returns, allowances and chargebacks; the use of controlled substances in the Company's products; the effect of current economic conditions on the Company's  industry, business, results of operations and financial condition; disruptions or failures in the Company's information technology systems and network infrastructure caused by third party breaches or other events; the Company's reliance on alliance and collaboration agreements; the Company's reliance on licenses to proprietary technologies; the Company's dependence on certain employees; the Company's ability to comply with legal and regulatory requirements governing the healthcare industry; the regulatory environment; the effect of certain provisions in the Company's government contracts; the Company's ability to protect its intellectual property; exposure to product liability claims; risks relating to goodwill and intangibles; changes in tax regulations; the Company's ability to manage growth, including through potential acquisitions and investments;  the integration of the acquired business of Tower Holdings, Inc. and Lineage Therapeutics Inc. by the Company being more difficult, time-consuming or costly than expected, operating costs, customer loss and business disruption (including, without limitation, difficulties in maintaining relationships with employees, customers, clients or suppliers) being greater than expected following the acquisition, the retention of certain key employees of the acquired business being difficult, the Company's and the acquired business's expected or targeted future financial and operating performance and results, the combined company's capacity to bring new products to market, and the possibility that the Company may be unable to achieve expected synergies and operating efficiencies in connection with the acquisition within the expected time-frames or at all, the restrictions imposed by the Company's credit facility and indenture; the Company's level of indebtedness and liabilities and the  potential impact  on cash flow available for operations; uncertainties involved in the preparation of the Company's financial statements; the Company's ability to maintain an effective system of internal control over financial reporting; the effect of terrorist attacks on the Company's business; the location of the Company's manufacturing and research and development facilities near earthquake fault lines; expansion of social media platforms and other risks described in the Company's periodic reports filed with the Securities and Exchange Commission. Forward-looking statements speak only as to the date on which they are made, and the Company undertakes no obligation to update publicly or revise any forward-looking statement, regardless of whether new information becomes available, future developments occur or otherwise.

References

[1] Parkinson's Disease Foundation website http://www.pdf.org/en/parkinson_statistics

Company Contacts:

Mark Donohue

Investor Relations and Corporate Communications

(215) 558-4526

www.impaxlabs.com

To view the original version on PR Newswire, visit:http://www.prnewswire.com/news-releases/impax-receives-positive-chmp-opinion-for-numient-levodopa-and-carbidopa-modified-release-capsules-for-the-symptomatic-treatment-of-adult-patients-with-parkinsons-disease-300149147.html

http://health.einnews.com/article/288260057/p-sbYg4qG6XVHuvr