Braeburn Pharmaceuticals announced that the first patients have been enrolled in its Phase 3 clinical study of Probuphine, a subdermal implant for the maintenance treatment of opioid dependence. The trial is designed to address questions the agency posed in its complete response letter last year, after its review of the original New Drug Application (NDA). Completion of the Braeburn Phase 3 study is expected by the middle of 2015, to be followed by resubmission of the NDA later in the year.
“With an estimated 2.2 million Americans suffering from opioid dependence, there is an acute need for innovative and effective treatment options,” said Behshad Sheldon, President and CEO of Braeburn Pharmaceuticals. “We believe the fast pace with which a number of sites received IRB approval following our recent investigator training indicates the addiction community’s support and need for novel treatments like Probuphine. Braeburn is committed to continue working with our clinical investigators to identify appropriate study patients and expedite enrollment in our Probuphine study.”
Braeburn held investigator training sessions in June to review clinical study procedures, including training for implant insertion and removal. To date, fifteen sites have obtained IRB approvals, and Braeburn expects an additional six sites to be operational within the next few weeks. Fourteen sites are actively screening patients for randomization into the study, and five patients have already been enrolled.
“For the vast majority of people with opioid dependence, medication-assisted therapy (MAT) is a critical component to achieve and sustain recovery; however, current options have limitations that may hinder compliance,” said Richard Rosenthal, professor of psychiatry, Icahn School of Medicine at Mount Sinai, Medical Director of Addiction Psychiatry at Mount Sinai Behavior Health System and Co-Lead Investigator of Braeburn’s Phase 3 Probuphine clinical study. “Given the escalating scope and gravity of the opioid addiction epidemic, there is no question more tools are needed to better arm patients against their life-threatening disease.”
The clinical study is a randomized, double-blind, double-dummy design that is expected to enroll approximately 180 patients into two parallel treatment arms. The study population consists of clinically stable patients who are receiving maintenance treatment with an FDA-approved sublingual formulation containing buprenorphine at a daily dose of 8 mg or less. Patients are being randomized to receive either four Probuphine implants, or to continue daily sublingual buprenorphine therapy. To enable the double-blind design, those receiving Probuphine implants are required to take daily placebo sublingual pills, while those continuing on their stable dose of sublingual buprenorphine pills are required to be treated with four placebo implants. The patients are expected to be treated for six months, and the primary analysis will be a non-inferiority comparison of responders in the two arms.
“This study is of particular interest to the addiction community because it focuses on people who have been stable on a relatively low dose of buprenorphine, a growing segment of the opioid dependent population that has seldom been the focus of clinical research,” said Frank Vocci, president, Friends Research Institute Inc. and Co-Lead Investigator of Braeburn’s Phase 3 Probuphine clinical study. “Providing stable patients with a long-acting treatment like Probuphine will ideally help them stay on track with their recovery, making Probuphine a natural next step treatment option for long-term recovery.”
Date: July 21, 2014
Source: Braeburn Pharmaceuticals