Titan Pharmaceuticals ($TTNP) emerged victorious from an FDA advisory committee meeting where the majority of non-agency experts backed approval of its drug against opioid addiction. While the agency hasn't made up its mind on the therapy, Probuphine, agency advisors voted in favor of approval in a 10-4 decision with one abstention on Thursday.
Probuphine is Titan's experimental product for delivering the approved drug buprenorphine with a device that is implanted under the skin for 6 months, designed to keep steady levels of the active drug in an addict's system and keep him off opioids such as oxycodone and codeine. And Titan marched to the FDA last year with an NDA after showing that treatment with its drug beat placebo and was non-inferior to sublingual buprenorphine tablets.
As an FDA staff report highlighted earlier this week from Titan's pivotal studies, there are challenges to treating opioid addicts. They pointed out in analysis that "after allowing four months for engagement in treatment, only three Probuphine-treated patients were fully abstinent from opioids" while just "8% provided negative samples for at least 80% of tests." And agency staff noted that "40%-62% of Probuphine-treated patients required supplemental buprenorphine, and 11-12% required supplemental buprenorphine even after receiving a fifth implant."
Nevertheless, agency advisers voted 10-5 in favor of the effectiveness of Probuphine. In a release, Titan also touted that the committee strongly supported the safety of its treatment in a 12-2 vote with one abstention. Yet with a 5-4 vote with 6 abstentions, the panel was more mixed on Titan's Risk Evaluation and Mitigation Strategy (REMS) program, to which U.S. regulators have not given their blessing. With an FDA action date of April 30, the agency will take its experts' votes into account in its decision on whether to approve Probuphine. But as industry regulars know, the agency doesn't have to follow the recommendations of advisory committees.
"We are pleased the Committee recognized the favorable benefit-risk profile of Probuphine and voted in strong favor of its approval," said Kate Glassman-Beebe, executive vice president and chief development officer of Titan, in a statement. "We look forward to working with the FDA to complete its review of Probuphine and remain committed to addressing the growing unmet needs in managing patients with opioid dependence."
- here's the release
- see the article from the San Francisco Business Times
FDA staff review raises big questions about fate of Titan's Probuphine
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