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 not worked.
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