Health and Healthcare

What the FDA Has to Say About Acadia Pharma's Parkinson's Treatment

Chris Lange

Published: September 21, 2018 11:50 am

Last Updated: January 11, 2020 5:32 pm

Acadia Pharmaceuticals Inc. (NASDAQ: ACAD) shares made a handy gain to close out the week after the company announced that the U.S. Food and Drug Administration (FDA) completed a post-marketing review and issued a clear statement reaffirming the positive benefit-risk profile of Nuplazid (pimavanserin) for patients with Parkinson’s disease psychosis (PDP).

Currently, Nuplazid is the only medicine approved in the United States to treat hallucinations and delusions associated with PDP. Nuplazid was approved by the FDA based on a pivotal Phase 3 study that demonstrated clinically robust and highly statistically significant efficacy, combined with other supportive studies.

Ultimately, the FDA did not identify any new or unexpected safety findings with Nuplazid, or findings that are inconsistent with the established safety profile currently described in the drug label. After a thorough review, FDA’s conclusion remains unchanged that the drug’s benefits outweigh its risks for patients with hallucinations and delusions of Parkinson’s disease psychosis.

Steve Davis, Acadia’s president and CEO, commented:

Nothing is more important to ACADIA than the wellbeing of the patients who use NUPLAZID. We are very pleased with the FDA’s clear statement reaffirming NUPLAZID’s positive benefit-risk profile. We are also pleased with the FDA’s conclusion that patients taking NUPLAZID for Parkinson’s disease psychosis should continue to use it as prescribed by their health care provider and its reminder that no other antipsychotic medication is approved for the treatment of PDP.

Shares of Acadia were last seen up about 4% at $19.82, with a consensus analyst price target of $31.56 and a 52-week trading range of $12.77 to $41.20.