FDA rejects Alkermes depression drug NDA

This article was originally published here


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.

Read the whole story on our sister site, Drug Delivery Business News

The post FDA rejects Alkermes depression drug NDA appeared first on MassDevice.

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