FDA approves first buprenorphine implant to treat opioid dependence

Probuphine--Courtesy of Titan Pharma

The FDA has approved the first buprenorphine implant to treat opioid dependence. The device, Probuphine, is marketed by small cap Titan Pharma ($TTNP) and privately held Braeburn Pharma, and is expected to be commercially available this summer.

The device is approved for patients who are already stable on low to moderate doses of other buprenorphine forms. Probuphine uses Titan's Proneura technology, which creates a solid rod from a mixture of ethylene-vinyl acetate (EVA) and a drug substance. It contains 80 mg of buprenorphine in four one-inch-long, flexible rods. They are inserted under the skin of a patient's upper arm by a certified healthcare provider, Titan Pharma said in a statement. Probuphine delivers a constant low dose of buprenorphine for 6 months, at the end of which it is surgically removed.

Buprenorphine is currently available in pill or film formulations that require the patient to self-administer the treatment daily. An implant that continuously delivers the drug would improve patient adherence, as well as deter misuse, diversion and accidental pediatric exposure, Titan said. It is intended to be used in a complete treatment program, alongside counseling and psychosocial support.

"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," FDA Commissioner Dr. Robert Califf said in an FDA statement about the Probuphine approval. "Today's approval provides the first-ever implantable option to support patients' efforts to maintain treatment as part of their overall recovery program." Back in February, Califf called for a "far-reaching action plan" to reexamine the agency's approach to opioids and to reverse the opioid "epidemic."

A randomized clinical trial in adults showed that the implant's effect was comparable to that of buprenorphine film: 63% of patients had no evidence of illicit opioid use during the 6 months of treatment, compared to the 64% of patients who responded to sublingual buprenorphine alone.

The device has a boxed warning that includes the risk of implant migration, protrusion, expulsion and nerve damage from the insertion and removal procedures. It was rejected in 2013 due to FDA concerns about "human factors testing of the training associated with Probuphine's insertion and removal."

South San Francisco, CA-based Titan granted exclusive commercialization rights in the U.S. and Canada to Princeton, NJ's Braeburn in 2012. Titan, which is worth about $330 million, will receive a $15 million milestone payment for the FDA approval and double-digit tiered royalties, the company said in the statement. It is eligible for sales milestones of up to $165 million and is exploring licensing opportunities outside the U.S.

- read the Titan statement
- here's the FDA statement