If Alkermes Antidepressant Can Get Past FDA, The Market Might Be There
Alkermes’s announcement of positive findings in the FORWARD-5 trial of its treatment-resistant depression drug ALKS 5461 came as a surprise, given the past two Phase III trials disappointed, but if it can gain approval, the buprenorphine/samidorphan product could meet an unmet need.
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On Track To Approval, Alkermes Hopes ALKS-5461 Can Change Future Of Depression Therapy
The novel opioid-system antidepressant is being positioned for adjunctive therapy on top of SSRIs, but Alkermes is eyeing other indications, and better ways to stratify and treat depressed patients.
FDA Reversal Puts Alkermes Depression Drug Back On Track For January Approval
Reversing an earlier decision, FDA accepted Alkermes' new drug application (NDA) for ALKS 5461 for review, with a target action date of Jan. 31. But the company could still face a tough FDA review.
Keeping Track: A Little Bit Of (Nearly) Everything
The latest drug development news and highlights from our US FDA Performance Tracker.