FDA to review drug-delivering implant for opioid addiction

The implant's manufacturer will present clinical trial results to the agency on January 12, with a decision on approval expected by the end of February.
By Stephen Feller  |  Jan. 11, 2016 at 10:35 AM
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WASHINGTON, Jan. 11 (UPI) -- The Food and Drug Administration on January 12 will convene an advisory committee to review trial data for probuphine, an implant containing two drugs that counteract the effects of opiods, for use as part of treatment for opioid-drug dependence.

Probuphine contains buprenorphine and naloxone and is implanted for treatment for six months. Dosage can be personalized for each patient, allowing a continuous stream of medication to help counteract cravings while treating an addiction.

Opioid addiction and overdose has exploded in recent years as patients treated with the drugs have developed dependencies, playing a role in the huge growth of heroin use across all age groups in the country.

The FDA previously held back on approving Probuphine during its first application for review in 2013, asking for further studies into appropriate dosage, efficacy and safety -- despite an advisory committee recommending approval. The drug combination was developed by Braeburn Pharmaceuticals and combined with a drug-delivery system called ProNeura, created by Titan Pharmaceuticals.

"The data from the final phase 3 trial, which was designed in collaboration with the FDA in response to questions raised in the complete response letter, is compelling and we look forward to presenting it on January 12," said Braeburn Pharmaceuticals President and CEO Behshad Sheldon in a press release. "More long-term treatments are needed to help people stay in recovery, and we remain excited about the potential for Probuphine to be the first of many new options for people with opioid addiction."

The companies completed a phase 3 clinical trial in June that included 178 patients who had been treated with suboxone, naloxone, or buprenorphine for at least three months before being enrolled.

Researchers reported that during the six-month trial, 88 percent of participants had not been found using illicit opioids.

Doctors involved with the trial said the ability to keep people from using drugs is a key part of long-term recovery, which they said the implant could help some patients do, though it is not by itself a solution to addiction.

"It's the same idea of putting a disease in remission. We want people to have a good quality of life and that always takes a little bit of conscious thought and effort," Dr. Michael Frost, an addiction medicine physician, told The Intelligencer. "Medication at the end of the day is just medication. And in the absence of developing skills and lifestyle modification, medication is not enough just on its own."

The FDA is expected to announce its decision on February 27.

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