Alkermes publishes positive data as US FDA reviews new depression treatment
Alkermes (Nasdaq: ALKS) has published Phase III data for ALKS 5461 (buprenorphine/samidorphan) in the adjunctive treatment of major depressive disorder (MDD).
The combo is being trialled as a new once-daily oral therapy for patients with an inadequate response to standard antidepressant therapies.
The Dublin-headquartered firm, which has a lot invested in the candidate, faced turbulence earlier in the year when the US regulator refused its initial application for the therapy, before having an immediate change of heart.
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