Titan Pharmaceuticals and Braeburn are parting ways over a licensing deal they inked back in 2012 for commercial rights to distribute Probuphine, a small implanted device about the size of a matchstick that dispenses a low-level dose of buprenorphine over six months.
Conditions for the termination agreement call for Titan to regain all rights to Probuphine in the U.S. and Canada. Braeburn will pay $1 million to Titan and agrees to assist in a transition lasting until the end of the year in order to maintain treatment continuity for patients and physicians.
"We believe that Probuphine is an important product in the face of a growing opioid addiction epidemic and we will continue to explore options with the potential to improve uptake of the product in the U.S., as well as expand global access through partnerships in Europe and other territories with Molteni & C. dei F.lli Alitti Società di Esercizio S.p.A. and Knight Therapeutics Inc. in Canada," Sunil Bhonsle, Titan’s president and CEO, said in a statement.
Probuphine, which was cleared by the FDA in 2016 after a rocky regulatory path, was developed by Titan Pharmaceuticals. Developers aimed at a maintenance dose targeting opioid receptors in the brain, helping reduce addict’s cravings while tamping down the effects of withdrawal.
The regulatory agency put the brakes on approval three years before giving the drug an OK even though a majority of its expert panel members voted in favor of marketing the drug/device at the time. The FDA said it wanted more evidence that a significant number of patients using the implant would actually be free of opioid use. They also wanted more data on proper dosing.