WINNIPEG, MANITOBA, Aug 13, 2014 (Marketwired via COMTEX) -- Medicure Inc. ("Medicure" or the "Company") CA:MPH -5.71% (otcqb:MCUJF), a specialty pharmaceutical company, announces that the preliminary results of its Phase IIa Clinical Trial, Tardoxal(TM) for the Treatment of Tardive Dyskinesia (TEND-TD) showed a non-statistically significant improvement in the primary efficacy endpoint in patients treated with Tardoxal. Medicure views these preliminary results as supportive of continuing the program and developing a modified formulation as a prelude to a larger, confirmatory Phase II study.
TEND-TD was planned as a 140 patient Phase II clinical trial to evaluate the efficacy and safety of Tardoxal for the treatment of Tardive Dyskinesia (TD), with a pre-planned interim analysis after approximately 40 patients were enrolled. The primary efficacy endpoint for the study was a decrease in involuntary movements as measured by the Abnormal Involuntary Movement Scale (AIMS), a standardized test used to detect and monitor TD and other movement disorders. The results from all 37 patients (17 randomized to Tardoxal and 20 to matching placebo) who completed the 12 week treatment period showed a trend to greater improvement in AIMS score from baseline to completion of study in the Tardoxal group versus placebo. The study was not adequately powered to assess efficacy and the improvement noted was not statistically significant. No significant differences between the study groups were seen in safety endpoints, however, there was a trend to increased nausea reported in the treatment group. This side effect was anticipated and has been seen in the Company's previous clinical studies with the product. As it was not feasible to complete an adequately powered study prior to expiry of the product and due to the Company's limited financial resources at that time, enrollment was stopped after attainment of the target number for the pre-planned interim analysis.
Further details on the results are not being released at this time pending additional evaluation in conjunction with the Principal Investigator, Dr. Gary Remington, Director of the Medication Assessment Clinic, Schizophrenia Program, Centre for Addiction and Mental Health and Professor and Schizophrenia Head, Division of Brain and Therapeutics, Department of Psychiatry, University of Toronto. The trial was conducted by Medicure's subsidiary, Medicure International, Inc. Further study information is available at: http://clinicaltrials.gov/ct2/show/NCT00917293?term=medicure&rank=5
"We are grateful to the investigators, staff and patients who participated in this study as we work to develop a safe and effective treatment for this debilitating condition," stated Dr. Albert D. Friesen, CEO of Medicure. "The results from TEND-TD give us sufficient confidence to maintain this program and to make plans for the next step in the advancement of Tardoxal. Continued progress and growth in our Aggrastat commercial business, has improved our ability to find value in other areas, such as revisiting and continuing our efforts with Tardoxal."
Medicure plans to maintain a modest investment in the research and development of Tardoxal over the next several months and is currently exploring modified formulations to reduce nausea that may be associated with use of the product. A larger, confirmatory Phase II study will be required to evaluate and confirm the safety and efficacy of Tardoxal in treatment of TD. Tardoxal is an experimental drug and has not been approved for commercial use by regulatory bodies such as the U.S. Food and Drug Administration (FDA) or Health Canada.
Tardoxal continues to have Fast Track designation from the FDA for the treatment of moderate to severe TD. Fast Track designation is designed to facilitate the development and expedite the review of new drugs that are intended to treat serious or life-threatening conditions and that demonstrate the potential to address unmet medical needs.