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FDA Breakthrough Therapy Designation: #50 For Parkinson’s Disease Psychosis

September 2, 2014

ACADIA Pharmaceuticals, a San Diego-based biopharmaceutical company focusing on the development of medicines for neurological and central nervous system disorders, announces September 2nd , that it has received the FDA Breakthrough Therapy Designation (BTD). The BTD is for Nuplazid (Pimavanserin) for the treatment of Parkinson’s Disease Psychosis (PDP).

Nuplazid, a once-a-day oral agent, is a selective serotonin inverse agonist preferentially targeting 5-HT2A receptors. 5-HT2A receptors are believed to play a key role in psychosis. ACADIA Pharmaceuticals holds worldwide rights to Nuplazid.

The FDA has agreed that a New Drug Application (NDA) for Nuplazid for PDP can be based on a successfully completed pivotal Phase III trial (“-020 Study”) for PDP and on additional supporting data from other studies. The NDA submission is planned for near the end of 2014. The results of the -020 Study are published in November 2013 in The Lancet. If Nuplazid is approved, it will be the first in a new class of drugs to treat psychosis.

ACADIA Pharmaceuticals are also conducting an open-label safety extension trial (-015 Study), consisting of patients who completed the -020 Study, as well as patients from previous PDP trials, who in the opinion of their treating physician, may benefit from continued treatment with Nuplazid. This open-label study coupled with a similar extension study in connection with an earlier Phase II PDP trial has generated long-term safety data on Nutplazid.

While PDP is the lead indication for Nuplazid, ACADIA Pharmaceuticals is also investigating the drug for other neurological and psychiatric disorders:

•   Alzheimer’s Disease Psychosis (ADP)

•   Schizophrenia.

PDP Facts

According to ACADIA Pharmaceuticals’ news release:

•   In the U.S., approximately 1 million suffer from PD

•   Worldwide, approximately 4 – 6 million suffer from PD

•   PDP occurs in about 40% of PD patients

•   No FDA-approved treatment for PDP

•   Consists of visual hallucinations and delusions

•   Associated with increased caregiver stress and burden, nursing home placement, increased morbidity and mortality.

Please Note : “IMG Carlingford Lough 0617” by Sarah777 at en.wikipedia [Public domain] | Wikimedia Commons.

Copyright © 2012-2014, Orphan Druganaut Blog. All rights reserved.

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