October 21, 2016
By Alex Keown, BioSpace.com Breaking News Staff
DUBLIN – Shares of Alkermes Plc are up more than 30 percent this morning after the company announced its experimental anti-depression drug ALKS-5461, significantly reduced symptoms in patients suffering from major depressive disorder who were not helped by standard treatments.
The pivotal Phase III Forward 5 efficacy trial showed a 2 milligram dose of ALKS 5461, a once-daily, oral investigational medicine, reduced depression scores compared to placebo as measured by 6-item Montgomery–Åsberg Depression Rating Scale. The 1mg dose of ALKS 5461 showed improvement in depressive symptoms in the study, but did not separate significantly from placebo, the company said. Following the positive results, the company plans to meet with the U.S. Food and Drug Administration to determine the steps the company needs to make as it seeks regulatory approval of ALKS-5461. That’s quite a turnaround for the drug in less than one-year’ time. In January, Alkermes reported that two of its three clinical trials studying ALKS 5461 in depression failed to meet their primary endpoints. At the time of the failures, Alkermes thought there was still potential in the drug through its Forward 5 Phase III study—and the released results have proven the company was justified in their beliefs.
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. The drug was granted Fast Track designation by the FDA in 2013.
The most common side effects patients taking ALKS 5461 experienced were nausea, dizziness and fatigue, which has been consistent with what was seen in earlier trials, the company said.
“We designed ALKS 5461 to have a novel mechanism of action for the treatment of MDD, a serious disease where new therapeutic options are highly sought after as millions of patients in the U.S. do not respond to standard courses of antidepressant therapy,” Elliot Ehrich, Alkermes’ chief medical o said in a statement. “With the successful completion of the FORWARD-5 study and data from more than 1,500 patients to date, we have established a strong foundation of evidence of ALKS 5461’s clinical utility in the adjunctive treatment of major depressive disorder.”
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 embodies our dedication to developing novel and safe CNS medicines that address compelling unmet needs faced by large numbers of patients,” Chief Executive Officer Richard Pops said in a statement. “Major depressive disorder affects millions of people and their families, and represents one of the greatest burdens of suffering and cost of any disease today. New drug development in the field is challenging and we are excited to advance ALKS 5461 in this important indication.”
Shares of Alkermes hit a morning high of $59.40 following Thursday’s closing price of $43.27.
