Alkermes plc may be best known for its drugs that treat addiction and schizophrenia -- and for a 2011 trans-Atlantic deal in which it bought an Irish drug maker, doubled in size, and moved from Waltham to Dublin.
But the biotechnology company got a new lift Wednesday, saying the Food and Drug Administration had granted fast-track status for its experimental medicine to combat depression, intended for patients who don’t respond to standard therapies.
The news, coming after Alkermes said it would launch a pivotal late-stage trial of the drug early next year, signaled the FDA’s interest in new medicines for major depressive disorders. About 11 million patients each year start taking drugs to treat depression-- most of them seeking to boost serotonin levels -- but roughly 60 percent of them don’t respond to the medications.
“There’s a compelling need for new depression medications that don’t rely on the serotonin pathway,” said Alkermes chief executive Richard F. Pops. Instead, he said, the company’s drug “influences the opioid pathway, but in a non-addictive way.”
News of the fast-track status sent Alkermes shares up $1.67 to $31.84 on the Nasdaq exchange Thursday, a 5.5 percent gain.
The designation will give Alkermes more access to FDA regulators during the clinical study of the drug, now called ALKS 5461, which was developed in the company’s Waltham labs. It could also qualify the medicine for a priority review, which would reduce the waiting time for an FDA ruling from a year to eight months after the company files its application for approval.
Pops, who divides his time between offices in Waltham and Dublin, said the company’s goal is to expand a portfolio of drugs developed by Alkermes and Elan Drug Technologies, the Irish company it bought two years ago for $960 million.
The company’s top research and development focus is on disorders of the central nervous system, which processes sensory information sent from the spinal cord to the brain. Its other products include Vivitrol, which treats alcohol and opioid dependence, and Risperdal Consta, a drug for bipolar disorder and schizophrenia.
“We think we’re developing one of the most important (central nervous system) drug pipelines in the pharma industry writ large,” Pops said.