FDA Applies Brakes to Schizophrenia Drug Approval Due to Manufacturing Concerns


Manufacturing issues stall progress with ALKS 3831, Alkermes’s promising new drug for the treatment of schizophrenia and bipolar I disorder.


The US Food and Drug Administration (FDA) shared a Complete Response Letter (CRL) to Alkermes regarding ALKS 3831, citing manufacturing issues, specifically problems with tablet coating in batches of the drug. Despite this, Alkermes sees a clear resolution on the horizon.

“We will continue to work closely with the Agency in an expeditious manner to support approval of ALKS 3831 for the treatment of schizophrenia and bipolar I disorder and believe we have a clear path to resolution. Importantly, there were no clinical issues identified in the CRL pertaining to ALKS 3831’s efficacy or safety, and no new studies were requested for approval of the application,” Craig Hopkinson, MD, chief medical officer and executive vice president of Research & Development at Alkermes, said to the press.1

Alkermes believes the tablet coating problems noted in the CRL were specific to certain development batches, and that these problems have since been resolved. The tablets in question, manufactured at a site in Wilmington, Ohio, showed signs of erosion. After identifying these tablets, Alkermes manufactured new batches without issue.2

Alkermes stated they have data to prove the resolution of these issues, which are being prepared for submission. Alkermes hopes the data will help resolve any concerns, thus allowing for ALKS 3831 to continue through the approval process.

This news follows the vote in favor of approval by an FDA advisory panel in October, which you can read more about in FDA Advisory Committee Votes in Favor of ALKS 3831. To hear more about the trials of ALKS 3831, watch Sharing the Results: ALKS 3831


1. Alkermes. Alkermes Receives FDA Complete Response Letter Related to ALKS 3831 Manufacturing Records Review. News release. November 17, 2020. https://investor.alkermes.com/news-releases/news-release-details/alkermes-receives-fda-complete-response-letter-related-alks-3831

2. Jensen K. FDA unexpectedly rejects Alkermes schizophrenia drug, citing manufacturing concerns. Biopharma Dive. November 17, 2020. https://www.biopharmadive.com/news/alkermes-schizophrenia-drug-fda-rejection/589199/

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