Alkermes (NASDAQ: ALKS), a global bio-pharmaceutical company valued at more than $8.5 billion, announced on Friday topline results from a phase 3 study called FORWARD which is examining the company’s therapy ALKS-5461.
ALKS 5461 is an oral medicine used for the treatment of major depressive disorder (MDD) in patients with an inadequate response to already available antidepressant therapies.
The purpose of the trial was to demonstrate that ALKS 5461 is able to show that patients who take the once daily therapy see significantly reduced symptoms of depression compared to a placebo.
The company was happy to report that patients receiving a 2mg dose of the therapy met the primary endpoint of significantly reducing depression scores compared to a placebo based on the industry standard six-item Montgomery-Asberg Depression Rating Scale. The drug also showed a statistically significant reduction in another commonly used tool, the 10-item MADRS scores.
In addition, patients who received a 1mg dose of ALKS 5461 also saw improvements in their depressive symptoms but the results were not significantly different enough compared to patients who received a placebo.
Now that the phase 3 trial has achieved its objectives, the company said that it will initiate a meeting with the U.S. Food and Drug Administration (FDA) and its Division of Psychiatric Products to discuss the steps needed to file for a Fast Track designation status.
Alkermes will present its comprehensive findings at an upcoming medical meeting and also submit the results for publication in a peer-reviewed journal.
“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,” saidElliot Ehrich, M.D., Chief Medical Officer of Alkermes. “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. With these data now in hand, we will move forward rapidly to meet with the FDA to determine the appropriate next steps toward a regulatory submission for ALKS 5461, with a goal of bringing this important new medication to patients with MDD.”