The U.S. Food and Drug Administration on Friday declined to approve Alkermes Plc’s opioid-based depression treatment, citing the need for additional data to prove the effectiveness of the drug.
The largely expected decision comes months after an advisory panel to the FDA strongly voted against the drug and raised questions on its safety and efficacy.
ALKS 5461 is a once-daily pill combining samidorphan and buprenorphine, designed to rebalance brain function that becomes dysregulated in the state of depression. It was developed as an add-on treatment for patients with major depressive disorder (MDD).
Suicide is one of the three leading causes of death in the United States, according to U.S. health authorities, and many cases result from untreated or poorly treated major depression.
However, depression is a tricky area of development that has largely been abandoned by big drugmakers, underscoring the need for new therapeutic options for the disorder.
MDD affects about 16.2 million Americans, of which nearly two-thirds do not respond to currently approved therapies.
To date, only three antipsychotic drugs have been approved as add-on treatments for MDD, including AstraZeneca Plc’s Seroquel. If approved, Alkermes’ treatment would have been the first opioid-based product for depression.
The company had first received a refusal to file letter from the FDA, stating that the agency was unable to complete its review of the drug due to lack of evidence of its effectiveness. The agency, weeks later, accepted the marketing application for the drug after discussions with Alkermes.
Alkeremes said on Friday it plans to meet with the FDA to discuss the potential next steps for ALKS 5461.