Braeburn Announces FDA's Acknowledgment of Receipt of Probuphine® NDA Resubmission; Agency Action Expected by February 27, 2016

PRINCETON, N.J., Sept. 28, 2015 /PRNewswire/ -- 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."

About Opioid Addiction
According to recent estimates, there are 2.2 million people with opioid dependence in the U.S. Approximately 20 percent of this population is addicted to illicit opioids, such as heroin, and the other 80 percent to prescription opioids, such as oxycodone, hydrocodone, methadone, hydromorphone and codeine. Before the year 2000, medication-assisted therapies for opioid dependence were available in the U.S. only from a limited number of approved facilities. The Drug Addiction Treatment Act of 2000 (DATA 2000) allowed medical office-based treatment of opioid dependence and greatly expanded patient access to medication-assisted treatment. Sales of buprenorphine drug products for the treatment of opioid addiction in 2014 were approximately $1.75 billion in the United States.

About Probuphine®

Probuphine is an investigational subdermal implant designed to deliver buprenorphine around the clock for six months following a single treatment, and to promote patient compliance and retention. Buprenorphine, which is the active ingredient in multiple FDA-approved drug products for the treatment of opioid dependence, is currently available in tablet and film formulations that require self-administration by patients on a daily basis.

Probuphine was developed using ProNeura™, Titan Pharmaceuticals' continuous drug delivery system that consists of a small, solid implant made from a mixture of ethylene-vinyl acetate (EVA) and a drug substance. The resulting construct is a solid matrix that is placed subdermally, normally in the upper arm, in an outpatient office procedure, and removed in a similar manner at the end of the treatment period.

The efficacy and safety of Probuphine has previously been studied in several clinical trials, including a 163-patient, placebo-controlled study over a 24-week period (published in the Journal of the American Medical Association (JAMA)), and a follow-on study of 287 patients (published in the journal Addiction).

About Braeburn Pharmaceuticals
Braeburn Pharmaceuticals, an Apple Tree Partners company, is a late-stage pharmaceutical company focused on novel, long-acting implantable and injectable therapies for serious neurological and psychiatric disorders, including addiction, pain, and schizophrenia. Long-acting therapeutic treatment options can be essential to improving patient outcomes and facilitating recovery in these conditions, which are often complicated by stigma and present significant public health challenges. Braeburn's investigational product pipeline includes: Probuphine®, a six-month buprenorphine implant for treatment of opioid addiction; CAM2038, weekly and monthly subcutaneous injection depot formulations of buprenorphine for treatment of opioid addiction and pain; a risperidone six-month implant for treatment of schizophrenia; and a novel molecule, ATI-9242, for treatment of schizophrenia. For more information on Braeburn, visit: www.braeburnpharmaceuticals.com.

Media contact:
Sonia Segal-Smith
MSLGROUP Boston
781-684-0770
[email protected]

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SOURCE Braeburn Pharmaceuticals

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