California-based Titan Pharmaceuticals, a company focusing on products for CNS disorders, has submitted its 6-month subdermal buprenorphine implant for approval with the FDA for the maintenance treatment of opioid dependence in adults. The submission includes a request for a priority review.
The implant, Probuphine, uses the company's ProNeura delivery system, in which a solid rod is inserted under the skin, normally in the upper arm, and releases the drug continuously. Titan believes that it is the first product designed to deliver 6 months of buprenorphine at a single dose.
This is a major market – there are around 6 million opioid addicts worldwide, including illegal and prescription opioids. Buprenorphine is a standard medication for the treatment of opioid dependence, and the 2011 market for the daily dose formulation was worth around $1.3 billion in the U.S. A sustained release and long-term version could improve compliance, and therefore reduce the impact of addition on addicts, their families and friends, and on society.
In September, an undisclosed potential licensee for Probuphine invested $4.25 million into the company, and has committed further resources to the commercialization of the implant, should it reach the market. The license option expires at the end of December.
- read the press release