Shares of Alkermes Soar on MDD Treatment Potential (ALKS)

Shares of Alkermes Plc (NASDAQ: ALKS) skyrocketed 16% in regular trading hours on Wednesday after the biopharmaceutical company said that its stage-2 clinical trial on the  unbranded drug called ALKS 5461 showed that it was effective in treating patients suffering from major depressive disorder (MDD). In a statement, the Company said that study conducted among 142 patients showed that the treatment ALKS 5461, which is a  one-a day, non-addictive oral medicine, “significantly reduced” depressive symptoms among patients.

Alkermes PLC, which is based in Dublin Ireland and has a research and development facility in Massachusetts, said on Wednesday that based on clinical observations, it will approach the Food and Drug Administration (FDA) to get an approval for latter stage studies.

Commenting over the development, Alkermers’ Senior Vice President – Research and Development, Chief Medical Officer, Elliot Enrich said in a statement, “ALKS 5461 has the potential to be a novel therapy with a unique mechanism of action for depression and validates our expertise with opioid (opium-like compound) modulators,”

“Based on the strength of these data, as well as the positive results seen in the prior clinical study, we will move forward rapidly to meet with the FDA and initiate a pivotal development program with a goal of bringing this important new medication to patients with MDD,” added Enrich.

“The improvements in depressive symptoms observed in patients treated with ALKS 5461 in this study were clinically meaningful and among the most robust I have seen in a phase 2 study for depression in the past two decades. This promising candidate could provide a valuable new treatment approach for this serious and chronic disease,” said  Dr. Maurizio Fava, who led the study at Massachusetts General Hospital, said in a press statement.

“There is significant unmet medical need for novel treatments with new mechanisms of action for depression, as many patients do not adequately respond to existing pharmacological therapies,” said Dr. Fava.