Titan Pharma Says FDA Approves Probuphine To Treat Opioid Dependence; Stock Up

(RTTNews) - Titan Pharmaceuticals, Inc. (TTNP) announced that the U.S. Food and Drug Administration has approved Probuphine or buprenorphine 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.

TTNP closed Thursday trading at $7.07, up $0.09 or 1.29 percent. In the after-Hours, the stock further gained $1.48 or 20.93 percent.

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.

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.

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.