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Phase 3 study shows positive findings for opioid addiction implant
Probuphine, a subdermal implant containing buprenorphine hydrochloride used for the long-term treatment of opioid addiction, was found to be noninferior in a phase 3 double-blind clinical study, according to a press release from the manufacturer, Braeburn Pharmaceuticals.
“Today’s results bring us one critical step closer to our goal of making long-acting buprenorphine products available to patients. We are grateful to the FDA for providing guidance on the study design and to our investigators for helping execute it. We hope these results pave the way for Probuphine, if approved by the FDA, to become a uniquely effective option in addiction treatment, enabling patients to manage their treatment more conveniently and giving doctors confidence that medication is delivered as intended, without worrying about it getting into the wrong hands or unintentionally harming children,” Behshad Sheldon, president and CEO of Braeburn, said in the release.
After the New Drug Application for Probuphine was not approved due to lack of supporting data, Braeburn pharmaceuticals worked in collaboration with the FDA to address the issues posed by the Complete Response Letter, issued in April 2013, regarding the drug’s efficacy.
The trial randomized 177 stable patients who were already receiving maintenance treatments of buprenorphine/naloxone, to receive six months of either the Probuphine implant or sublingual tablets. Results demonstrated that the Probuphine group (88%) were more likely to have no evidence of illicit drug use for all 6 months of the trial, as sampled by a urine test, compared with the control group (72%; P = .008).
The investigational subdermal implant is designed to release a continuous dose of buprenorphine hydrochloride for six months after one treatment. Probuphine will encourage greater patient compliance and retention, compared with the current patient administered tablet and film formulations of buprenorphine that are currently on the market for the treatment of opioid dependence, according to the release.
Braeburn intends to resubmit the New Drug Application later this year. The drug application is still considered to be a priority review to the FDA, according to the press release.
“The development of medications like Probuphine is critical to addressing the tremendous unmet need for new and effective addiction treatment options. Braeburn strongly believes in the potential of Probuphine, to offer people living with opioid addiction a unique approach to achieving sustained, long-term recovery. We remain committed to working with the FDA toward the goal of adding Probuphine to the short list of proven medication-assisted treatment options,” Frank E. Young, MD, PhD, executive vice president, regulatory and medical affairs, Braeburn Pharmaceuticals, said in the release.