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FDA Panel Backs Approval of Pimavanserin

March 29, 2016

FDA Panel Backs Approval of Pimavanserin

Big News for Advanced Parkinson’s
 

March 29, 2016, 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.  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 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.