SOUTH SAN FRANCISCO, CA--(Marketwire - 06/30/11) - Titan Pharmaceuticals, Inc. (OTC.BB:TTNP - News) today provided an update on its recent communications with the U.S. Food and Drug Administration (FDA) regarding the Statistical Analysis Plan (SAP) for the company's confirmatory Phase 3 study of Probuphine™ for patients with opioid dependence.
Based upon its ongoing dialogue with the FDA and to maintain the trial's clinical integrity, Titan will conduct primary efficacy analyses comparing the Probuphine and placebo arms using the trial's protocol-specified primary endpoint of the cumulative distribution function of the percent negative urine samples, as well as an additional analysis of this urine toxicology that will incorporate patients' self-reports of illicit opioid use, as requested by the FDA. Specifically, this additional analysis comparing the Probuphine and placebo arms incorporates patients' self-reported data to ensure that within the assessment time period, the number of positive urine test results correspond to at least the number of days of opioid use reported by the patient. Titan has retrospectively conducted this same type of analysis on the cumulative distribution function of the percent negative urines incorporating patient self-report data from its first controlled Phase 3 study (PRO-805) of Probuphine in patients with opioid dependence, with the findings fully supporting the previously reported positive results. The FDA has indicated that it will put primary emphasis on this additional efficacy analysis when reviewing any New Drug Application for the approval of Probuphine.
With this clarity around the trial's Statistical Analysis Plan, Titan will now commence the unblinding and analysis of the data from its Phase 3 confirmatory clinical trial and expects to report top-line results in July 2011.
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