Alkermes (NSDQ:ALKS) said last Friday that the FDA rejected the company’s new drug application for its ALKS 5461 drug intended to treat patients with major depressive disorder. The Dublin, Ireland-based company’s ALKS 5461 once-daily oral medication is a fixed dose combination of buprenorphine and samidorphan, designed for patients with MDD for whom standard antidepressant therapies have […]
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In reversal, FDA accepts Alkermes’ depression drug for review
In an about-face, the FDA reportedly agreed to review a new drug application for Alkermes‘ (NSDQ:ALKS) depression drug just weeks after the agency said it would only do so if the company conducted additional trials. Alkermes’ once-daily oral medication is a fixed dose combination of buprenorphine and samidorphan, designed for patients with major depressive disorder […]
FDA refuses to review application for Alkermes’ depression drug
Alkermes (NSDQ:ALKS) shares tumbled this morning after the company revealed that the FDA will not review its application for an investigational depression drug. The U.S. regulatory issued a refusal to file letter to Alkermes, writing that it can’t review the drug’s application based on “insufficient evidence of overall effectiveness for the proposed indication,” and that […]
