Shares of the biopharmaceutical group Alkermes (NASDAQ:ALKS) are slipping Tuesday after the US Food and Drug Administration issued a pessimistic review of its experimental drug for depression, ALKS-5461.
The future of the drug will be subjected to debate by an FDA advisory panel on Thursday who are tasked with issuing a recommendation about whether regulators should approve the drug next year.
But the briefing documents released ahead of Thursday’s debate take a scathing view of the drug’s safety data, its components as well as the trial design for the drug.
In particular, the committee argues that it isn’t proven that ALKS-5461, which is made up of the opioid buprenorphine as well as samidorphan, isn’t as addictive as an opioid drug.
“Although the applicant has made several arguments that the other component of their drug, samidorphan, negates the opioid properties of buprenorphine, this has not been conclusively proven,” wrote the advisers in the briefing documents released on Tuesday.
Regulators also criticized the study’s design in the briefing documents, inferring that it fails to offer enough insight on the efficacy of ALKS-5462 in treating major depressive disorders.
The FDA’s panel of advisers will convene on Thursday to debate and reach an opinion to provide to the FDA, which must ultimately decide on whether to approve the drug.
Major depressive disorder – which ALKS-5461 aims to treat – affects more than 16.1 million American adults or about 6.7% of the US population over the age of 18, according to the Anxiety and Depression Association of America, a US non-profit.
Alkermes shares were trading down 1.7% at $39.69 in Tuesday’s afternoon trading session.
Contact Ellen Kelleher at [email protected]