FDA accepts Braeburn's resubmission of Probuphine NDA for review

Sep 28 2015

Braeburn Pharmaceuticals, an Apple Tree Partners company, today announced that the U.S. Food and Drug Administration (FDA) has accepted Braeburn's resubmission of the Probuphine New Drug Application (NDA) for review and set February 27, 2016 as the target date for Agency action. Probuphine®, licensed from Titan Pharmaceuticals, Inc. (OTCQB:TTNP), is an investigational, six-month buprenorphine HCl subdermal implant for the long-term maintenance treatment of opioid addiction. The Probuphine NDA resubmission includes results from a Phase 3 double-blind, double-dummy clinical study of Probuphine completed in May 2015.

"The FDA's acceptance of the Probuphine NDA resubmission brings us one step closer to providing an innovative and potentially transformative treatment option to patients with opioid dependence," said Behshad Sheldon, President and CEO of Braeburn Pharmaceuticals. "We are pleased to have submitted Probuphine for marketing approval at a time when stakeholders and policymakers at the national, state and local levels are searching for effective ways to increase access to high-quality and comprehensive addiction treatment while reducing the risk of diversion, misuse, abuse, and accidental exposure."

On September 17, 2015, U.S. Health and Human Services Department (HHS) Secretary Sylvia Burwell announced that HHS intends to revise regulations to "provide a balance between expanding the supply of [buprenorphine], encouraging use of evidence-based [medication-assisted treatment], and minimizing the risk of drug diversion." Long-acting buprenorphine implants and injectables are poised to play an important role in a comprehensive strategy to address the nation's opioid abuse epidemic, consistent with HHS's stated objectives. "If approved by the FDA, Probuphine has the potential to transform buprenorphine treatment by providing an evidence-based outpatient therapy that assures patients get the medicine they need while minimizing the risks of diversion and abuse," said Jonathan M. Young, Vice President, Policy, Braeburn Pharmaceuticals.

"We have appreciated the FDA's insights and guidance in developing the NDA resubmission," said Frank E. Young, MD, PhD, Executive Vice President, Regulatory and Medical Affairs, Braeburn Pharmaceuticals. "We are pleased with the new data and information included in our NDA resubmission and we look forward to working closely with the FDA during the review process to help provide this important treatment option to patients who could benefit from it."