Clinical Trials

Iloperidone

In four short-term and three long-term trials comprising over 3,500 patients, iloperidone demonstrated efficacy and reduced side effects.

Vanda submitted a New Drug Application (NDA) with the U.S. Food and Drug Administration (FDA) for Iloperidone in September 2007. A PDUFA (FDA action) date is set for July 27, 2008.

Probuphine®

Probuphine is Titan’s novel, proprietary, potential long-term treatment for opioid addiction and chronic pain. Titan is conducting a randomized, double-blind, placebo controlled, multi-center Phase III clinical study of Probuphine in the potential treatment of opioid addiction. This trial was fully enrolled, ahead of expectations, in December 2007 and Titan expects the results of this trial in the third quarter of 2008.

Additionally, we are initiating a program for Probuphine for the potential treatment of chronic pain and expect to make tangible progress toward beginning a Phase II study in this indication this year.

Spheramine®

In July 2008, Titan announced that Spheramine did not meet the Phase IIb clinical study’s primary or secondary endpoints, with no significant differences detected between the Spheramine and sham surgery arms of the study. The Phase IIb trial was designed to explore the safety, tolerability and efficacy of Spheramine.