It comes after two negative clinical trials announced in January this year.
The group now plans to meet with the powerful US Food and Drug Administration (FDA) to determine if the data from all three trials can support a filing for a new treatment for depression.
In the 407-patient trial, the drug, ALKS 5461 was found to significantly reduce symptoms of depression compared with a placebo, according to initial results released by the company.
Alkermes‘ chief medical officer Elliot Ehrich, said: “We designed ALKS 5461 to have a novel mechanism of action for the treatment of major depressive disorder, 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.
“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.”
ALKS 5461, a once-daily pill combining samidorphan and buprenorphine, is designed to rebalance brain function that becomes dysregulated in the state of depression.
Story by ProactiveInvestors