After being turned down by an FDA panel in November, Alkermes plc’s (ALKS) New Drug Application for ALKS 5461 awaits the final decision on January 31, 2019.Proposed for the adjunctive treatment of major depressive disorder in patients with an inadequate response to standard antidepressant therapies, ALKS 5461 is a once-daily, oral investigational fixed-dose combination of buprenorphine, a partial mu-opioid receptor agonist and kappa-opioid receptor antagonist, and samidorphan, a mu-opioid receptor antagonist, in the form of a sublingual tablet.The panel had voted 21 to 2 that the drug’s benefit-risk profile is not adequate to warrant its approval.The regulatory agency usually follows the decisions of its panels, although it is not mandatory.If approved, the Company expects ALKS 5461, which has a novel mechanism of action, to be a "blockbuster".ALKS closed Friday’s (Dec.21, 2018) trading at $28.45, down 4.40%.