Back In November, Titan Pharmaceuticals, Inc. (OTCMKTS:TTNP) completed enrollment in the Phase III trial PRO-814 so as to support re-filing of the new drug application for lead drug Probuphine. The enrollment process was completed in almost four months compared to planned time of six months. The Phase III study us expected to resolve key issues highlighted by the U.S. FDA, and mentioned in complete response letter released in 2013 after the original NDA was reviewed.
PRO-814
Titan’s PRO-814 study can be defined as a double dummy design, randomized, and double blind trial that will have 180 enrollments into two different treatment wings. The people enrolled in the study are clinically stable patients who are being treated with an accepted sublingual formulation containing ‘buprenorphine’ and administered daily (8 mg or less).
The trial
Titan reported that subjects under study will be randomized so that they can either opt for Probuphine implants, or can continue with their daily sublingual buprenorphine maintenance dosage. It is different from the previous NDA that demanded use of Probuphine in enrollments who are opioid addicts and for the first time getting buprenorphine therapy. Under the Phase III study, the subjects will be administered for six months. It will be a non-inferiority review of responders in two distinct treatment groups.
The experts view
The experts at Seeking Alpha anticipate Titan to release the data of PRO-814 clinical trial mid-2015. The results are expected to be released in this month. The ongoing study is funded by Braeburn while Titan is contributing with logistical support. The company helped Braeburn in the CMC regulatory as well as clinical preparation efforts of the Probuphine.
In last trading session, the stock price of Titan declined more than 2% to close the trading session at $0.797. The decline came at a share volume of 329,414 compared to average share volume of 388,274.
