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ACADIA Pharmaceuticals Inc. (NASDAQ:ACAD) stock gained over 15% in pre-market trading hours today, as the Food and Drug Administration (FDA) briefed the upcoming Psychopharmacologic Drugs Advisory Committee (PDAC) meeting —on March 29— related to a priority review of Nuplazid. The document showed positive signs for the drug’s future conduct, as FDA emphasized on the benefits compared to placebo. However, on the negative side, the drug showed a significantly high comparative death rate. The FDA highlighted that the company has submitted a New Drug Application (NDA) on the back of just one trial meeting primary endpoint, along with three other trials as supportive information. None of the three supportive trials showed statistical significance on primary endpoint. The authority mentioned that generally the Division of Psychiatry Products (DPP) requires efficacy evidence from more than one trial. However, it is within the authority of FDA to approve a drug based on one robustly positive trial, especially when there is supportive information attached to it from early stages of the development program. On September 3, 2015, the company submitted Nuplazid NDA for the treatment of psychosis in Parkinson’s disease. The company backed its application by providing positive results from its phase 3 pivotal study, which evaluated efficacy, tolerability, and safety of Nuplazid in patients suffering from Parkinson’s. The drug was granted a breakthrough therapy designation and also put under priority review by FDA on the company’s request. Acadia’s Nuplazid phase 3 pivotal trial (ACP-103-020) showed strong positive results. It met its primary endpoint of being statistically better to placebo at decreasing symptoms of psychosis in PD patients, as measured by the Scale for the Assessment of Positive Symptoms in Pakinson’s disease (SAPS-PD). However, the drug holds high risk as there were more deaths in Nuplazid treated group compared to placebo. At present, ACAD shares are trading up 19.65% at $20.31, as of 9:15 AM EDT. The stock is highly active in pre-market trading today, as more than 340,000 shares have already exchanged hands.
Source: Bidness ETC
SCS LLC has not been compensated for this article.
SCS LLC was previously compensated up to twenty thousand dollars each by star media llc for the mention of INVT and XXII however those contracts have expired.