WELCOME TO OUR PARKINSON'S PLACE!

I HAVE PARKINSON'S DISEASES AND THOUGHT IT WOULD BE NICE TO HAVE A PLACE WHERE THE CONTENTS OF UPDATED NEWS IS FOUND IN ONE PLACE. THAT IS WHY I BEGAN THIS BLOG.

I COPY NEWS ARTICLES PERTAINING TO RESEARCH, NEWS AND INFORMATION FOR PARKINSON'S DISEASE, DEMENTIA, THE BRAIN, DEPRESSION AND PARKINSON'S WITH DYSTONIA. I ALSO POST ABOUT FUNDRAISING FOR PARKINSON'S DISEASE AND EVENTS. I TRY TO BE UP-TO-DATE AS POSSIBLE.

I AM NOT RESPONSIBLE FOR IT'S CONTENTS. I AM JUST A COPIER OF INFORMATION SEARCHED ON THE COMPUTER. PLEASE UNDERSTAND THE COPIES ARE JUST THAT, COPIES AND AT TIMES, I AM UNABLE TO ENLARGE THE WORDING OR KEEP IT UNIFORMED AS I WISH. IT IS IMPORTANT TO UNDERSTAND I AM A PERSON WITH PARKINSON'S DISEASE. I HAVE NO MEDICAL EDUCATION,

I JUST WANT TO SHARE WITH YOU WHAT I READ ON THE INTERNET. IT IS UP TO YOU TO DECIDE WHETHER TO READ IT AND TALK IT OVER WITH YOUR DOCTOR. I AM JUST THE COPIER OF DOCUMENTS FROM THE COMPUTER. I DO NOT HAVE PROOF OF FACT OR FICTION OF THE ARTICLE. I ALSO TRY TO PLACE A LINK AT THE BOTTOM OF EACH ARTICLE TO SHOW WHERE I RECEIVED THE INFORMATION SO THAT YOU MAY WANT TO VISIT THEIR SITE.

THIS IS FOR YOU TO READ AND TO ALWAYS KEEP AN OPEN MIND.

PLEASE DISCUSS THIS WITH YOUR DOCTOR, SHOULD YOU HAVE ANY QUESTIONS, OR CONCERNS. NEVER DO ANYTHING WITHOUT TALKING TO YOUR DOCTOR FIRST..

I DO NOT MAKE ANY MONEY FROM THIS WEBSITE. I VOLUNTEER MY TIME TO HELP ALL OF US TO BE INFORMED.

I WILL NOT ACCEPT ANY ADVERTISEMENT OR HEALING POWERS, HEALING FROM HERBS AND ETC. UNLESS IT HAS GONE THROUGH TRIALS AND APPROVED BY FDA. IT WILL GO INTO SPAM.

THIS IS A FREE SITE FOR ALL WITH NO ADVERTISEMENTS

THANK YOU FOR VISITING! TOGETHER WE CAN MAKE A DIFFERENCE!

TRANSLATE

Monday, January 25, 2016

U.S. FDA approves BOTOX (onabotulinumtoxinA) for the treatment of lower limb spasticity in adults

January 25, 2016

Allergan plc, a leading global pharmaceutical company has announced that the U.S. Food and Drug Administration (FDA) has approved BOTOX® (onabotulinumtoxinA) for the treatment of lower limb spasticity in adult patients to decrease the severity of increased muscle stiffness in ankle and toe muscles. BOTOX® is the first and only botulinum toxin product to be approved by the FDA to treat multiple muscle groups of the upper (elbow, wrist, fingers, and thumb) and lower limbs that may be impacted by spasticity.
BOTOX® was first approved for the treatment of upper limb spasticity (ULS), or increased muscle stiffness in the elbow, wrist and fingers, in adults in March 2010. Additional FDA approval was received in April 2015 to expand the BOTOX® label for the treatment of adults with ULS to include the addition of two thumb muscles. It is not known whether BOTOX® is safe or effective to treat increased stiffness in upper limb muscles other than those in the elbow, wrist, fingers, and thumb, or to treat increased stiffness in lower limb muscles other than those in the ankle and toes. BOTOX® has not been shown to help people perform task-specific functions with their upper limbs or increase movement in joints that are permanently fixed in position by stiff muscles. Treatment with BOTOX® is not meant to replace your existing physical therapy or other rehabilitation that your doctor may have prescribed.
"Spasticity is a debilitating condition that can have a significant impact on patients' lives, compromising their ability to perform a range of daily activities," said Mitchell F. Brin, M.D., Senior Vice President Global Development and Scientific Officer, BOTOX®. "This FDA approval marks our continued commitment to partnering with scientists and researchers around the world to explore the potential benefits of BOTOX® in treating specific medical conditions. We are pleased that through this research, we are now able to offer this treatment option for patients with lower limb spasticity."
Spasticity is a condition in which there is an abnormal increase in muscle tone or stiffness of muscle, which may interfere with movement, or be associated with discomfort.i Affecting approximately 1 million people in the U.S., spasticity is usually caused by damage to the portion of the brain or spinal cord that controls voluntary movement.ii The most common causes of spasticity include stroke, adult cerebral palsymultiple sclerosistraumatic brain injury, spinal cord injury, physical trauma, or infection.ii
"In my experience, stroke survivors are among the most prominent groups to be impacted by spasticity affecting the upper and lower limbs; and it is critical to continue seeking treatment from a physician specially trained to manage spasticity," said Alberto Esquenazi, M.D., John Otto Haas Chair and Professor, Department of Physical Medicine and Rehabilitation; Director, Gait & Motion Analysis Laboratory, MossRehab, and a lead investigator in the studies. "The results reinforce the efficacy and safety of BOTOX®, and physicians can now have even greater confidence when offering their patients another approach to treating these specific muscles." 
The FDA approval was based on a large, international development program that included a phase three, multi-center, double-blind, randomized, placebo-controlled clinical trial that evaluated the safety and efficacy of BOTOX® compared to placebo in more than 400 patients with lower limb spasticity following stroke. The study compared a total BOTOX® dose of 300 to 400 units divided among ankle and toe muscles (n=233) to placebo (n=235). Statistically significant improvements were observed in the two co-primary endpoints of average change from baseline in the improvement of muscle tone measured by the Modified Ashworth Scale (MAS) ankle score and the clinical benefit for patients as assessed by the Clinical Global Impression of Change by Physician (CGI) at weeks 4 and 6 (p<0.05). The most frequently reported adverse reactions (>2%) were arthralgia (3%), back pain (3%), myalgia (2%), upper respiratory tract infection (2%) and injection site pain (2%). The safety profile observed in the study was consistent with the known safety profile of BOTOX®.
Indications: BOTOX® (onabotulinumtoxinA) is a prescription medicine that is injected into muscles and used to treat increased muscle stiffness in elbow, wrist, finger, thumb, ankle, and toe muscles in people 18 years and older with upper and lower limb spasticity.
It is not known whether BOTOX® is safe or effective to treat increased stiffness in upper limb muscles other than those in the elbow, wrist, fingers, and thumb, or to treat increased stiffness in lower limb muscles other than those in the ankle and toes. BOTOX® has not been shown to help people perform task-specific functions with their upper limbs or increase movement in joints that are permanently fixed in position by stiff muscles. Treatment with BOTOX® is not meant to replace your existing physical therapy or other rehabilitation that your doctor may have prescribed.
http://www.medicalnewstoday.com/releases/305534.php?tw

No comments:

Post a Comment