Our Parkinson's Place: ACADIA Pharmaceuticals : Files New Drug Application for NUPLAZID for the Treatment of Parkinson's Disease Psychosis

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!

Sunday, September 13, 2015

ACADIA Pharmaceuticals : Files New Drug Application for NUPLAZID for the Treatment of Parkinson's Disease Psychosis

09/13/2015

ACADIA Pharmaceuticals reported it has submitted a New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) seeking approval for NUPLAZID (pimavanserin) for the treatment of psychosis associated with Parkinson's disease.

In a release, the Company noted that NUPLAZID is an SSIA (selective serotonin inverse agonist) preferentially targeting 5- HT2A receptors. Through this novel mechanism, NUPLAZID has demonstrated significant efficacy in Parkinson's disease psychosis (PDP) and has the potential to avoid many of the debilitating side effects of existing antipsychotics, none of which are approved for use in PDP patients. The FDA granted NUPLAZID Breakthrough Therapy designation for PDP in 2014.

"NUPLAZID holds promise for patients with Parkinson's disease psychosis who currently have no FDA-approved treatment options," said Steve Davis, ACADIA's Chief Executive Officer. "Psychosis is the leading cause for Parkinson's patients moving from their homes to nursing homes or other institutions and leads to an increased risk of mortality, a diminished quality of life and significant caregiver burden. If approved, NUPLAZID would represent a new and distinctly different pharmacological approach to treating psychosis and would be the first drug approved in the United States for psychosis associated with Parkinson's disease."

According to the National Parkinson Foundation, about one million people in the United States and from four to six million people worldwide suffer from Parkinson's disease. An estimated 40 percent of these patients have Parkinson's disease psychosis, which is characterized by hallucinations and delusions. Currently, there is no FDA-approved therapy to treat Parkinson's disease psychosis.

ACADIA said that its NDA submission is based on data from a comprehensive development program assessing the safety and efficacy of NUPLAZID for Parkinson's disease psychosis. The NDA includes data from the pivotal Phase III -020 Study, in which NUPLAZID met all primary and secondary endpoints with statistical significance, along with supportive data from other studies with NUPLAZID. The -020 Study demonstrated that NUPLAZID significantly reduced psychosis compared to placebo in patients with Parkinson's disease psychosis with no worsening of motor function. These results were further supported by significant improvements in all secondary efficacy measures and by significant benefits in exploratory efficacy measures of nighttime sleep, daytime wakefulness and caregiver burden. Consistent with previous studies, NUPLAZID was safe and well tolerated in the -020 Study. Detailed results of the -020 Study have been published in The Lancet.

ACADIA has requested a Priority Review of its NDA. If granted, Priority Review status would accelerate the review timeline from ten months to six months following the conclusion of the 60 calendar day filing review period that begins on the FDA's receipt of the NDA. The FDA informs the applicant of a Standard or Priority Review designation following the conclusion of this 60 calendar day period.

ACADIA is a biopharmaceutical company focused on the development and commercialization of medicines to address unmet medical needs in central nervous system disorders.

More information:

www.acadia-pharm.com

((Comments on this story may be sent to newsdesk@closeupmedia.com))

http://health.einnews.com/article/286057594/ZBEXoeV46ra1Qn-6