Titan Pharmaceuticals wins FDA approval for Probuphine to treat opioid dependence

The Probuphine subdermal implant, which utilizes Titan’s proprietary ProNeura technology, delivers buprenorphine continuously for up to six months.

The product is expected to be commercially available this summer and is recommended for use as part of a complete treatment program including counseling and psychosocial support.

"The approval of Probuphine marks a major milestone for Titan and we look forward to supporting our partner Braeburn Pharmaceuticals during the product launch this summer," said Titan President and CEO Sunil Bhonsle.

"At a time when the government is supporting the expansion of access to opioid addiction treatments, the launch of Probuphine will provide the medical community with a novel, long-term treatment alternative that can provide benefits to many patients suffering from this disease."

"As a clinician who has treated hundreds of patients for opioid addiction, including as a clinical investigator in the Probuphine studies, I am very encouraged by the prospects of this new treatment," said Dr. Genie Bailey, Associate Clinical Professor of Psychiatry, Brown University and Director of Research, Stanley Street Treatment & Resources, Fall River, Massachusetts.

"It’s extremely important that patients maintain their addiction treatment once they’ve stabilized on daily dosing of buprenorphine. Probuphine’s method of continuously delivering buprenorphine provides for long-term maintenance and offers the potential for enhanced patient compliance and a better quality of life."

Buprenorphine is the most commonly prescribed medication for the treatment of opioid dependence. Until today, it has only been available in daily dosed sublingual (oral) formulations. Probuphine offers the potential to address issues associated with oral buprenorphine such as poor compliance, misuse, diversion and accidental pediatric exposure. Each Probuphine implant contains 80 mg of buprenorphine hydrochloride.

Four flexible Probuphine implants, each about the size of a small matchstick, are inserted by a certified healthcare provider just under the skin of the inside of the patient’s upper arm through a simple in-office procedure and are removed in a similar manner at the end of treatment.

"As a family medicine doctor with a specialty in addiction medicine, and as a Probuphine clinical investigator, I have seen the benefits of Probuphine firsthand. Probuphine’s ability to provide around-the-clock, stable levels of buprenorphine for six months significantly benefits patients and clinicians by assisting with compliance and by decreasing the possibility of abuse or diversion. The hands-on training program for qualified health care providers enhances the ease and safety of both the implant insertion and removal process," said Dr. Matthew A. Torrington, FASAM, ABAM, Senior Master Trainer: Probuphine REMS program and a clinical research physician at UCLA.

The product label emphasizes safety considerations associated with the insertion and removal procedures for Probuphine. Details describing the risks and complications associated with the insertion and removal procedures, as well as rare but serious complications that may result from improperly inserting the implants are included in the Probuphine Prescribing Information. Because of these risks, only certified healthcare providers may insert or remove Probuphine implants.

Probuphine will only be available through a restricted distribution program (REMS) that includes required training for provider certification. Please see below in the ‘Indication and Important Safety Information’ section for additional details.

"We believe Probuphine will be an important tool in fighting the serious and complex disease of opioid addiction, and on behalf of Titan, I especially want to thank the patients, clinical investigation teams, NIDA, the FDA, and our partner Braeburn Pharmaceuticals for the exceptional effort that resulted in this approval," said Kate Beebe, Ph.D., Titan’s executive vice president and chief development officer.

Titan granted exclusive commercialization rights to Probuphine in the U.S. and Canada to Braeburn in 2012 and is currently exploring licensing opportunities outside of the U.S. Under the Braeburn license, Titan will receive a $15 million milestone payment for the FDA approval as well as double-digit tiered royalties, and is eligible for sales milestones of up to $165 million.

"The Titan Board of Directors commends all those who have worked so hard over the years to make approval of Probuphine a reality," said Marc Rubin, M.D., Titan’s executive chairman.

"Our goal is to continue adding value to the company by building a strong pipeline of ProNeura-based product candidates. We are now well positioned to devote increasing resources to our Parkinson’s disease and hypothyroidism programs and will continue to evaluate additional opportunities for ProNeura."