Titan plans Q3 NDA submission for controlled-release implantable addiction treatment

Titan Pharmaceuticals ($TTNP) now envisions an NDA submission to the FDA for its implantable, controlled release treatment for opioid dependence during its fiscal 2012 third quarter. The South San Francisco-based company announced the news Feb. 9 while promoting encouraging results from a 6-month safety retreatment study of Probuphine, which itself followed encouraging Phase III results released in July. Titan said the drug continues to be well-tolerated, safe and appears to effectively reduce opioid dependence and help control withdrawal and cravings. Probuphine uses Titan's ProNeura continuous drug delivery system, which is implanted under the skin in the upper arm. A patient with the implant gets a 6-month, round-the clock steady dose of the anti-addiction drug buprenorphine (in a new formulation), after which the implant is typically removed or replaced with a new implant. Release


Using AI and RWD to Uncover Rare Disease Insights, Accelerate Commercialization and Improve Patient Outcomes

Wednesday, March 24 | 2pm ET / 11am PT

Learn how IPM.ai transformed real world data into real world insights to assist Audentes in their development of AT132 for the treatment of XLMTM. The session reviews how IPM.ia and Audentes collaborated to uncover the XLMTM patient population.