FDA approves Titan’s Probuphine implant for opioid dependence

The FDA has approved Titan Pharmaceuticals’ (NASDAQ:TTNP) Probuphine implant, the first product for the long-term maintenance treatment of opioid dependence in clinically stable patients on 8 mg or less a day of oral buprenorphine.

“Opioid abuse and addiction have taken a devastating toll on American families. We must do everything we can to make new, innovative treatment options available that can help patients regain control over their lives,” said FDA commissioner Robert M. Califf, M.D. in a statement. “Today’s approval provides the first-ever implantable option to support patients’ efforts to maintain treatment as part of their overall recovery program.”

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,” he added.

Titan granted exclusive commercialization rights to Braeburn in 2012 for Probuphine in the U.S. and Canada 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.

“Our goal is to continue adding value to the company by building a strong pipeline of ProNeura-based product candidates,” said Dr. Marc Rubin, executive chairman of Titan.

“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,” he added.

Braeburn president and CEO, Behshad Sheldon, said patients and their doctors now have Probuphine as a new option for the six-month treatment of opioid dependence.

“Opioid addiction is a chronic disease and should be treated the same way we treat other serious, chronic diseases – with evidence-based medicine,” she added.

Dr. Kelly Clark, president elect of the American Society of Addiction Medicine, and CMO of CleanSlate Centers, said Probuphine represents a significant step forward in addressing the serious lack of new treatment options in the last 15 years.

“With strong support from the president and the secretary of Health and Human Services this year to expand access to medication assisted treatment, addiction specialists like myself are more confident we will be able to get more patients the treatment they desperately need,” he added.

Buprenorphine is the most commonly prescribed medication for the treatment of opioid dependence. It has only been available in daily-dosed 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.