FDA approves first buprenorphine implant for opioid dependence
The US Food and Drug Administration (FDA) has approved Probuphine, which is the first buprenorphine implant for the maintenance treatment of opioid dependence.
Previously, buprenorphine was only approved in pill or film form for the treatment of opioid dependence. The implant is designed to provide a constant, low-level dose of buprenorphine for six months in patients who are already stable on low-to-moderate doses of other forms of buprenorphine, as part of a complete treatment program. In clinical trials, 63% of Probuphine-treated patients had no evidence of illicit opioid use throught the six months of treatment.
This approval of an additional treatment for opioid dependence forms a central part of the FDA’s action plan on opioids, which aims to reverse the epidemic that the painkillers have in the US. FDA commissioner, Robert Califf, says: “Opioid abuse and addiction have taken a devastating toll on American families. We must do everything we can to make new, innovative treatment options available that can help patients regain control over their lives. Today’s approval provides the first-ever implantable option to support patients’ efforts to maintain treatment as part of their overall recovery program.”
The implant was developed by Titan Pharmaceuticals (NASDAQ: TTNP) who expect it to be made available this summer. President and CEO, Sunil Bhonsle, comments: “The approval of Probuphine marks a major milestone for Titan. At a time when the government is supporting the expansion of access to opioid addiction treatments, the launch of Probuphine will provide the medical community with a novel, long-term treatment alternative that can provide benefits to many patients suffering from this disease.”
Titan entered into an exclusive commercialisation rights to Probuphine in the US and Canada to Braeburn Pharmaceuticals in 2012. Under the terms of the agreement, Titan will receive a $15 million milestone payment upon FDA approval and up to $165 million in sales royalties.