Oct 152013

POSTED ON Tuesday, October 15, 2013  FOR ALKS 5461

Irish biotechnology firm Alkermes has received fast-track designation for its proprietary investigational medicine ALKS 5461 from the US Food and Drug Administration (FDA).

Fast-track designation was granted for the adjunctive treatment of patients with major depressive disorder (MDD) who don’t respond to standard therapies. The process intended to speed-up the review of drugs, which treat serious conditions and fill an unmet medical need.

see a presentation

Ehrich ALKS 5461 Presentation…t=1

2013 Alkermes. All rights reserved. ALKS 5461: Rethinking. Psychiatry With. Opioid System Modulation. Alkermes R&D Day. July 17, 2013. Elliot Ehrich, M.D..

The drug, ALKS 5461, “significantly reduced” symptoms of depression in the 142-patient study, from the second of three phases of clinical trials generally required for regulatory approval, Alkermes said today in a statement. Based on the results, the company plans to request a meeting with the U.S. Food and Drug Administration and start later-stage studies.“We had been deliberately modest with folks over the last year because it’s so potentially important we thought we should be skeptical until we see a confirmatory study,” Alkermes Chief Executive Officer Richard Pops said in a telephone interview today. “The result was so clear when we un-blinded that it was self-evident that we needed to keep going.”

Patients Tested
Alkermes’s drug was tested in patients for whom other medicines, called selective serotonin reuptake inhibitors and serotonin-norepinephrine reuptake inhibitors, haven’t worked as well as hoped. Treatments in those classes include Eli Lilly & Co. (LLY)’s Prozac and Cymbalta. ALKS 5461 was tested on top of drugs patients were already taking as that may be the way the medicine would be used if approved, Pops said.

“This is a potentially very important positive development for Alkermes as ALKS 5461 is an oral, once-a-day drug which has a novel mechanism of action for treating MDD, which represents a very large market opportunity,” Cory Kasimov, an analyst with JPMorgan Chase & Co. (JPM), wrote in a research note today.

About 16.1 million people in the U.S. experience major depressive disorder, or MDD, each year and many don’t get enough of a benefit from the first antidepressants they try, according to Alkermes. Of about 10 million patients who receive treatment for MDD, two-thirds aren’t adequately helped and try a second therapy, Pops said.

ALKS 5461 is a combination of another compound, ALKS 33, and buprenorphine, a therapy that stimulates the opioid system and is approved for treatment of addiction to opioids such as heroin.

The company decided to test the combination based on the premise that opioids have been shown to help in treatment of depression. The problem was their addictive properties, Pops said. ALKS 33 is an opioid receptor blocker, and its use is designed to combat addictive effects.

“We wanted to know if you can decouple the addictive properties of an opioid from antidepressive properties,” Pops said. With ALKS 5461, “we’re pushing the gas and the brake at the same time.”

Alkermes is equipped to start a bigger trial on its own, and may talk with pharmaceutical companies about partnerships to sell the drug outside the U.S. if it’s approved, Pops said, noting “it’s too early” to discuss commercial plans


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