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FDA Panel Backs Approval of Pimavanserin

Big News for Advanced Parkinson’s

Washington, D.C. — Today, an FDA advisory board voted to approve Acadia Pharmaceutical’s new antipsychotic medication, pimavanserin, which will be marketed under the name Nuplazid™. Previously, there was no FDA-approved drug for the treatment of psychosis in Parkinson’s, and expert neurologists and psychiatrists had the option of several atypical antipsychotic medications, none of which were proven effective in Parkinson’s, or one that was proven effective but had a fairly negative safety profile, with patients requiring weekly blood tests to make sure that they were tolerating the drug well.

However, with the lack of an FDA-approved drug for Parkinson’s disease psychosis, this troubling and sometimes terrible symptom is frequently untreated or, worse yet, treated with an antipsychotic medication that is not safe for Parkinson’s patients.  Many antipsychotic drugs work by blocking dopamine A chemical messenger (neurotransmitter) that regulates movement and emotions..  Since Parkinson’s is a disease where dopamine producing neurons are lost, blocking dopamine is bad – we think that sometimes it is fatal.

The approval of a drug to treat Parkinson’s disease psychosis will mean that there is a clear option for patients.  These are powerful drugs, so there are risks associated with any antipsychotic treatment – an issue presented to the FDA’s panel by Marc Stone, MD, the FDA’s Deputy Director of Safety – and so patients and families need to be careful and talk to their neurologist about all their options.  However, with FDA approval, we can hope that most patients with Parkinson’s will have access to a drug designed just for them and for Parkinson’s.

During the public comment period, many patients spoke about the impact of psychosis on their family.  These powerful testaments – many of which were from people who had participated in the clinical trial A research study in humans that aims to test a new intervention – this could be a drug, surgery or therapy like exercise or diet guidelines – to make sure it is effective and safe. of pimavanserin – described the impact of the drug in a way that went far beyond the numbers from the trial results.  Some people told us of the total resolution of hallucinations and delusions in a spouse, parent, or grandparent from taking pimavanserin in the clinical trial and others talked about how their spouse realized that hallucinations were not real, thanks to the treatment.

David Pickar, MD, a key member of the Psychopharmacologic Drugs Advisory Committee, pointed out that he felt that this was not for Parkinson’s disease psychosis, but rather for psychosis in patients being treated for Parkinson’s disease, because every patient in the study was receiving clinically optimized medication to manage their motor symptoms.  This is an important point, but also largely an academic one – since psychosis is usually seen later in the disease, use of this drug will be almost exclusively in treated Parkinson’s.

Hopefully, this success of the process for pimavanserin will inspire others to aggressively pursue novel therapies for Parkinson’s.  We hope that this approval will lead to better outcomes for people with Parkinson’s today and that this success of the drug approval process will inspire others to pursue the next breakthrough.

Peter N. Schmidt, Ph.D., Senior Vice President, Chief Mission Officer

Dr. Schmidt can be reached at pschmidt@parkinson.org.

Tuesday, March 29, 2016
In Memory of Robert Traurig
Wednesday, July 18, 2018

The Parkinson’s Foundation mourns the loss of emeritus board member Robert (Bob) Traurig. From 2004 to 2015, he was a member of the Foundation’s board of directors. Bob is survived by his wife Jacqueline, his daughters Madeline Sackel and Wendy Traurig.

New Study Shows 1.2 Million People in the United States Estimated to be Living with Parkinson’s Disease by 2030
Tuesday, July 10, 2018

Parkinson’s Foundation Reveals Most Comprehensive Estimate of
Parkinson’s Prevalence in North America since the 1970’s

Parkinson’s Foundation Elects Howard D. Morgan Chairman of the Board
Tuesday, June 26, 2018

MIAMI & NEW YORK — June 26, 2018 — The Parkinson’s Foundation today announced the election of Howard D. Morgan as chairman of its board of directors. Mr. Morgan, who previously served as the Vice Chair of the nonprofit organization’s board, is a Partner and the Senior Managing Director of Argand Partners in New York.

Parkinson’s Foundation Announces Five New Members of its People with Parkinson’s Advisory Council
Wednesday, June 13, 2018

NEW YORK & MIAMI — June 13, 2018 — The Parkinson’s Foundation today announced five new members of its People with Parkinson’s Advisory Council.

The Parkinson’s Foundation 2018 Gala in New York City Tuesday, May 8, 2018
Monday, May 14, 2018

The Parkinson’s Foundation 2018 Gala was held at Cipriani 25 Broadway in New York City on Tuesday, May 8, 2018.

Parkinson’s Foundation Adds Alison Herman to its Board of Directors
Tuesday, May 8, 2018

MIAMI – May 9, 2018 – The Parkinson’s Foundation today announced the election of Alison Herman to its board of directors. Herman is senior counsel at Southern Glazer’s Wine & Spirits, a company which has generously supported Parkinson’s Foundation fundraisers.

Statement on Nuplazid Drug
Tuesday, April 10, 2018

On 4/9/18, CNN published an article on the FDA-approved drug, Nuplazid, used to treat hallucinations and psychosis in Parkinson’s disease. The article investigates FDA data showing the number of reported deaths with people taking Nuplazid. Nuplazid was approved by the FDA in 2016 and is manufactured by Acadia Pharmaceuticals.

Parkinson’s Foundation Adds John D. Thomopoulos to its Board of Directors
Monday, March 19, 2018

MIAMI & NEW YORK – March 19, 2018 – The Parkinson’s Foundation today announced the election of John D. Thomopoulos to its board of directors. Thomopoulos is a partner at Ernst & Young.

In Memory of Edythe Kay Marsa
Monday, March 12, 2018

The Parkinson’s Foundation mourns the loss of emeritus board member, Edythe (Edy) Kay Marsa. From 1993 to 2014, she was a member of the Foundation’s board of directors and served on several committees. Edy is survived by her husband William Marsa, who founded the Herbert Kay Parkinson Chapter in honor of her first husband who passed away due to complications from Parkinson’s disease.

Parkinson’s Foundation Announces New Genetic Initiative Connecting Parkinson’s Genetic Data with Clinical Care
Tuesday, March 6, 2018

MIAMI & NEW YORK—March 6, 2018—The Parkinson’s Foundation today announced a new initiative offering genetic testing and counseling to Parkinson’s patients within its Center of Excellence network.

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