The Psychopharmacologic Drugs Advisory Committee of the FDA voted 12-to-5 in favor of approving Titan Pharmaceuticals’ (NASDAQ:TTNP) 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 FDA accepted the NDA for Probuphine last September and set an action PDUFA date for Feb. 27.
At the meeting, Titan’s partner, closely-held Braeburn Pharmaceuticals, presented efficacy data from the most recent clinical trial, confirmingthe effectiveness of Probuphine as a six-month maintenance treatment for opioid dependence in the population studied.
Multiple sensitivity analyses were also presented 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, and its proposed Risk Evaluation and Mitigation Strategy.
“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 the meeting, the few, current options are not enough to address the tremendous needs of the vast population dealing with this complex disease,” Braeburn president and CEO, Behshad Sheldon, said in a statement.
Titan president and CEO, Sunil Bhonsle, said new treatment options for the millions of patients and their families suffering from opioid addiction are desperately needed, and Titan and Braeburn appreciate the committee’s comprehensive review of Probuphine.
“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,” Mr. Bhonsle said.
“As a subdermal implant, Probuphine could increase patient compliance, decrease the risk of diversion and improve patients’ quality of life,” he added. “We look forward to the agency completing its review of the NDA.”
An open public hearing was included as part of the 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.”