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Alkermes’ depression treatment fails to get FDA panel backing

Advisory panel votes down opioid-based drug on concerns over safety and efficacy

Alkermes chief executive Richard Pops said he was disappointed by the vote of the FDA advisory panel on its new drug for major depressive disorder. Photograph: Dara Mac Dónaill

Saumya Joseph
Fri Nov 2 2018 - 11:55

An advisory panel to the US Food and Drug Administration voted against approving a treatment for depression developed by Irish-based company Alkermes for patients with an inadequate response to standard antidepressant therapies.

The decision comes two days after FDA staff reviewers flagged the potential for abuse with the opioid-based depression treatment and raised questions on its efficacy.

"I don't feel the evidence that was presented was substantial to show that there was efficacy ... I'm not convinced there is a big enough treatment effect to make a clinical difference," said Terri Warholak, a panel member.

Add-on treatment

The panel voted 21-2 against the drug, ALKS 5461, a once-daily pill combining samidorphan and buprenorphine developed as an add-on treatment for major depressive disorder, saying the data did not support a favourable benefit-risk profile.

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ALKS 5461 is designed to rebalance brain function that becomes dysregulated in the state of depression and was seen as a driver of future revenue for the Dublin-based drugmaker.

FDA staffers in the review published before the advisory panel meeting also questioned the non-availability of trial data on the effects of the treatment on unborn infants when the treatment was administered to pregnant women.

Alkermes share price was down 8.6 per cent at $37.31 by Friday afternoon trading in the US.

– Reuters

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