A late-stage trial for an injectable treatment for addiction to heroin and other opioids was successful, potentially adding to the stable of treatments for the growing epidemic of opioid abuse, Braeburn Pharmaceuticals and Camurus AB said Monday.
The trial follows a May U.S. Food and Drug Administration approval of another treatment option from Braeburn: a long-lasting arm implant that provides six months’ worth of the drug—buprenorphine.
Full results of the study are expected to be presented at a conference in April and the company then plans to submit the drug for approval by mid-2017.
The new weekly and monthly injection option could potentially help more addicts stay on the drug, which eases cravings for opioids and prevents withdrawal symptoms. Buprenorphine is currently available as tablets and films that dissolve in the mouth, the company said. Addicts sometimes run out of doses or skip them and use narcotics instead, or sell them to other addicts.
More than 47,000 Americans died of drug overdoses in 2014 and about 650,000 Americans received buprenorphine to treat opioid addiction in 2014.
Safety profiles were comparable between the two treatment groups, with few serious adverse events.
The Phase 3 study enrolled 428 patients with opioid use disorder and exceeded its original goal by being superior to the current tablet treatment. Phase 3 clinical trials are typically the last phase before a drug seeks FDA approval.
Shares of Camurus rose 16% in Stockholm trading Monday.
By Austin Hofford - The Wall Street Journal/Nov. 14, 2016
Photo: T. J. Kilpatrick, wsj