$TTNP PH3 study update for Probuphine

SOUTH SAN FRANCISCO, CA -- (MARKET WIRE) -- 06/17/11 -- Titan Pharmaceuticals, Inc. (OTCBB: TTNP) today announced additional information following on its press release issued earlier today about its ongoing dialogue with the U.S. Food and Drug Administration ( FDA ) regarding the Statistical Analysis Plan (SAP) for its confirmatory Phase 3 study of Probuphine™.
The SAP for the confirmatory Phase 3 study of Probuphine™ was submitted to the FDA in the third quarter of last year and included statistical analyses similar to those previously agreed upon with the FDA and performed in the first controlled Phase 3 study. In late March this year Titan received comments from the FDA on the study protocol as a whole that included a comment on the primary analysis which needed further clarification. Titan immediately requested a meeting with the FDA to obtain further clarification.
In early May, Titan and FDA met via teleconference, clarifying the earlier comment and reaching an understanding on a type of additional analysis to be performed. The revised SAP submitted to the FDA included this analysis as an additional secondary endpoint. Titan also provided to the FDA this same type of analysis conducted retrospectively on the data from the first controlled Phase 3 study (PRO-805), which fully supported the previously reported positive results.
The letter from the FDA received yesterday essentially agrees with the proposed statistical analysis methodology, but requests that this be part of the primary analysis. Titan is seeking a telephonic meeting with the FDA to obtain clarity regarding their request and finalize the SAP expeditiously, and conduct the appropriate analyses. Additional information on the timeline will be provided following this discussion with the FDA .
Importantly, Titan has not unblinded the database nor analyzed any findings for the Phase 3 confirmatory trial and will not do so until final agreement on the SAP has been reached with the FDA