FDA knocks back Alkermes’ opioid-based depression therapy over lack of evidence

pharmafile | February 4, 2019 | News story | Sales and Marketing |  Alkermes, FDA, major depressive disorder, pharma, rejection 

Alkermes experimental opioid-based depression therapy ALKS 5461 has been rejected by the FDA, it has emerged, in the adjunctive treatment of major depressive disorder (MDD).

The US agency confirmed the decision in a complete response letter, refusing to approve the drug in its current form. Alkermes has been requested to provide additional data to support its efficacy, and the company, in turn, confirmed that it would meet with the FDA to discuss how these concerns could be rectified.

The manufacturer did not state whether it would continue development of the therapy, only noting that this decision will be taken in light of its meeting with the FDA.

The FDA’s rejection comes after strong opposition from an agency advisory panel which questioned both the product’s safety and efficacy.    

The drug, a once-daily combination of samidorphan and buprenorphine, is aiming to become the first opioid-based treatment approved for MDD, a condition which affects 16.2 million in the US alone, two-thirds of which do not respond to currently available therapies.

Matt Fellows