Shares of Alkermes plc are down about 19 percent in premarket trading after the U.S. FDA rejected the company’s NDA for its major depressive disorder treatment ALKS-5461.
Shares of Alkermes plc are down about 19 percent in premarket trading after the U.S. Food and Drug Administration rejected the company’s New Drug Application for its major depressive disorder treatment ALKS-5461.
In a Refusal to File letter the FDA said it could not accept the drug because it needs to see more data. The regulatory agency said it is unable to complete a review based on “insufficient evidence of overall effectiveness for the proposed indication.”
“…additional well-controlled clinical trials are needed prior to the resubmission of the NDA for ALKS 5461,” the FDA added in its letter.
Additionally, the FDA requested the conduct of a bioavailability study to generate additional bridging data between ALKS 5461 and the reference listed drug, buprenorphine.
In a statement this morning Alkermes, as could be expected, said it “strongly disagrees” with the FDA’s letter and it plans to appeal the decision in order to avoid years of additional clinical trials. Alkermes said it intends to request a Type A meeting to determine the appropriate steps and see what information the company could provide to support a resubmission of its NDA.
Alkermes Chief Executive Officer Richard Pops said the company is disappointed with the decision and the implications it potentially has for MDD patients.
“We strongly believe that the clinical development program, including data from more than 1,500 patients with MDD, provides substantial evidence of ALKS 5461’s consistent antidepressant activity and a favorable benefit-risk profile,” Pops said in a statement.
Major depressive disorder (MDD) impacts about 17 million people each year. MDD is a condition in which patients exhibit depressive symptoms, which includes a depressed mood, a consistent loss of interest or pleasure in daily activities for at least a two-week period and also demonstrate impaired social, occupational, educational or other important functioning.
ALKS 5461 is a proprietary, investigational, once-daily oral medicine that acts as a balanced neuromodulator in the brain and represents a novel mechanism of action for treating MDD. ALKS 5461 consists of samidorphan and buprenorphine, and is designed to rebalance brain function that is dysregulated in the state of depression.
Alkermes filed its NDA at the end of January based on positive data from its Phase III FORWARD-5 trial. That study, completed in late 2016, showed a 2 milligram dose of ALKS 5461 reduced depression scores compared to placebo as measured by 6-item Montgomery–Åsberg Depression Rating Scale. It was a big turnaround for the drug after Alkermes reported that two of its three clinical trials studying ALKS 5461 in depression failed to meet their primary endpoints.
While Alkermes scrambles to avoid additional trials, the company said it is evaluating the impact of the Refusal to File letter on its previously-issued financial guidance for 2018. Any update will be provided in its first quarter 2018 financial results disclosures, the company said.
