Titan Pharmaceuticals has secured approval from the US Food and Drug Administration for its Probuphine (buprenorphine) implant to treat opioid dependence in clinically stable patients on 8 mg or less a day of oral buprenorphine.
Using Titan’s ProNeura technology, the Probuphine subdermal implant provides buprenorphine continuously for about six months.
Probuphine implant is suggested for use as part of a complete treatment program, including counseling and psychosocial support
According to the company, four flexible Probuphine implants will be inserted by a certified healthcare provider under the skin of the inside of the patient’s upper arm through a simple in-office procedure.
These will be removed in a similar manner at the end of treatment.
Titan Pharmaceuticals president and CEO Sunil Bhonsle said: "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.
"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."
Braeburn received exclusive commercialization rights to Probuphine in the US and Cananda in 2012.
The company is currently exploring licensing opportunities outside of the US. Under the deal, Titan will secure a $15m milestone payment for the FDA approva, in addition to double-digit tiered royalties.
The company is also eligible for sales milestones of up to $165m.