Titan Pharmaceuticals, Inc. and partner Braeburn Pharmaceuticals announced that the Psychopharmacologic Drugs Advisory Committee (PDAC) of the U.S. Food and Drug Administration (FDA) voted 12 to 5 in favor of approving Probuphine, the first long-acting, subdermal buprenorphine implant for the maintenance treatment of opioid addiction, in stable patients receiving 8mg or less per day of buprenorphine. The Committee’s vote followed presentation and discussion of data regarding Probuphine’s efficacy, safety, and risk-benefit profile. The New Drug Application (NDA) for Probuphine was resubmitted to the FDA in August 2015, and accepted by the FDA in September 2015. A target agency action date has been set for February 27, 2016.
At the meeting, Braeburn presented efficacy data from the most recent clinical trial confirming the effectiveness of Probuphine as a six-month maintenance treatment for opioid dependence in the population studied. Multiple sensitivity analyses were also presented by both Braeburn and the FDA to evaluate the robustness of the results, which consistently favored Probuphine. Braeburn also presented summary safety findings with a focus on the Probuphine insertion and removal procedures. Braeburn’s proposed Risk Evaluation and Mitigation Strategy (REMS) was presented jointly by Braeburn and the FDA.
“Medication offers the best chance for people with opioid addiction to sustain recovery, but as evidenced by the moving comments from patients, physicians and advocates at today’s meeting, the few, current options are not enough to address the tremendous needs of the vast population dealing with this complex disease,” said Braeburn Pharmaceuticals President and CEO Behshad Sheldon. “Our vision is to bring change to this underserved population. We are fully committed to making a lasting impact on the way this disease is treated.”
“New treatment options for the millions of patients and their families suffering from opioid addiction are desperately needed, and we appreciate the Committee’s comprehensive review of Probuphine," said Titan Pharmaceuticals President and CEO Sunil Bhonsle. "Probuphine has the potential to be the first marketed product to provide maintenance treatment of opioid addiction continuously for six months following a single procedure. As a subdermal implant, Probuphine could increase patient compliance, decrease the risk of diversion and improve patients' quality of life. We look forward to the Agency completing its review of the NDA."
An open public hearing was included as part of Advisory Committee Meeting, and demonstrated the public’s intense desire for new treatment options like Probuphine, to become available for people with opioid addiction. For over an hour, patients, advocates, physicians and clinical trial investigators spoke urging the Committee to recommend approval of Probuphine. In addition to these remarks, several letters were read, including one from mental health and addiction activist Rep. Patrick J. Kennedy, who stated, “Adding Probuphine to the short list of approved products to treat addiction is a first step in meeting the goals of government officials, while offering patients a long-term option for treatment. The active agent, buprenorphine, is already the go-to choice for providers and patients alike. The ability to now deliver the medication in a safer way for individuals, their families and society is truly a breakthrough.”
The FDA is not obligated to follow the recommendations of its Advisory Committee, but will consider the Committee’s guidance as it completes its review of the Probuphine NDA.
