Committee advises against FDA approval of Alkermes' novel depression drug

Alkermes has been knocked back with the disappointing, though not entirely unexpected, news that the FDA-appointed Psychopharmacologic Drugs Advisory Committee and the Drug Safety and Risk Management Advisory Committee did not see fit to recommend its investigational depression drug in the US.  

ALKS 5461, as the therapy is known, was turned down as an adjunctive treatment for major depressive disorder (MDD) in patients who have proved unresponsive to conventional treatments. The drug acts as an opioid system modulator, combining the partial mu-opioid receptor agonist and kappa-opioid receptor antagonist buprenorphine and the mu-opioid receptor antagonist samidorphan.

The committee judged that it could not support the drug’s approval as its benefit/risk profile was not determined to be strong enough. The FDA is not beholden to the decision, but it is likely to influence the outcome of its final judgement at the end of January 2019.

"We were disappointed and surprised by the FDA's characterisation of the safety and efficacy data for ALKS 5461 and the resulting outcome of the Advisory Committee vote, particularly for the patients, their families and treatment providers who need and deserve access to novel therapies that work differently than currently available antidepressants," commented Alkermes CEO Richard Pops. "We remain steadfast in our commitment to make a meaningful difference in the lives of people suffering with serious mental health conditions, and will continue to work with the FDA as it completes its review of the ALKS 5461 regulatory submission."

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