US Federal health advisers have recommended approval for an experimental implant designed to treat patients recovering from heroin and painkiller addiction.
Despite shortcomings in company studies, a majority of Food and Drug Administration advisers say the implant offers important benefits not currently available.
The drug-oozing device is intended to be a safer, more reliable approach to controlling cravings and withdrawal symptoms.
"Overall the data did have some problems," said Dr Thomas Grieger, of the Maryland Department of Health. "But I think clearly there was no evidence of significant risk with this agent and there is evidence of significant benefit and hopefully great promise."
The advisers voted 12-5 in favour of the device from Braeburn Pharmaceuticals. The FDA is scheduled to make its formal decision by February 27.
The matchstick-size implant, dubbed Probuphine, slowly releases a low dose of buprenorphine over six months.
Currently buprenorphine is available as a pill or film that dissolves under the tongue. It is considered a safer, more palatable alternative to methadone, the decades-old standard for controlling opioid addiction.
Opioids are a powerful family of drugs that mimic the opium poppy, including medications like oxycodone and illicit narcotics like heroin.
Braeburn executives told panellists on Tuesday that its implant could help reduce cases of relapse among chronic drug abusers.
Many recovering addicts struggle to stick with their daily medication, putting them at risk of returning to illicit drug use and overdosing.
But panellists questioned whether Braeburn's studies accurately predict Probuphine's success. They cited shortcomings in the company's research, including missing urine samples from some study participants.
Additionally, many patients received additional drug therapy to control their cravings and symptoms, clouding the picture of the implant's performance.
The FDA previously rejected Probuphine in April 2012, judging the drug's dose was too low to reliably help the broad range of opioid-addicted patients.
Another concern raised Tuesday involved the complex surgical procedure needed to put in and remove the rod-like implants, which are inserted under the skin of the arm.
According to an FDA review, problems like bleeding and infection were more frequent with Probuphine than with contraceptive implants that use similar drug-releasing technology.
Braeburn CEO Behshad Sheldon said on Tuesday the company would aim to train 1500 physicians to perform the procedure in the initial six weeks after launch.
