You can now read 5 articles in a month for free on BostonGlobe.com. Read as much as you want anywhere and anytime for just 99¢.

Experimental drug to treat depression granted fast-track status

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.

Continue reading below

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.

Robert Weisman can be reached at robert.weisman@globe.com. Follow him on Twitter @GlobeRobW.
Loading comments...
Subscriber Log In

We hope you've enjoyed your 5 free articles'

Stay informed with unlimited access to Boston’s trusted news source.

  • High-quality journalism from the region’s largest newsroom
  • Convenient access across all of your devices
  • Today’s Headlines daily newsletter
  • Subscriber-only access to exclusive offers, events, contests, eBooks, and more
  • Less than 25¢ a week
Marketing image of BostonGlobe.com
Marketing image of BostonGlobe.com
Already a subscriber?
Your city. Your stories. Your Globe.
Yours FREE for two weeks.
Enjoy free unlimited access to Globe.com for the next two weeks.
Limited time only - No credit card required!
BostonGlobe.com complimentary digital access has been provided to you, without a subscription, for free starting today and ending in 14 days. After the free trial period, your free BostonGlobe.com digital access will stop immediately unless you sign up for BostonGlobe.com digital subscription. Current print and digital subscribers are not eligible for the free trial.
Thanks & Welcome to Globe.com
You now have unlimited access for the next two weeks.
BostonGlobe.com complimentary digital access has been provided to you, without a subscription, for free starting today and ending in 14 days. After the free trial period, your free BostonGlobe.com digital access will stop immediately unless you sign up for BostonGlobe.com digital subscription. Current print and digital subscribers are not eligible for the free trial.