Expands Enrollment with Addition of Trial Site in India
WINNIPEG, Jan. 23, 2012 /CNW/ - Medicure Inc. ("Medicure" or the "Company") (TSX VENTURE:MPH)(PINKSHEETS:MCUJ) is pleased to provide an update and announce the addition of a site in India for its ongoing Phase II Clinical Trial,TardoxalTM for the Treatment of Tardive Dyskinesia (TEND-TD). The company has received approval from the Drug Controller General of India and anticipates enrollment in India to begin in February 2012. The trial is approved in the United States, by the Food and Drug Administration (FDA), and in Canada, by Health Canada, where sites are actively recruiting patients.
The addition of the new trial site (Schizophrenia Research Foundation, Chennai, India) is expected to increase the rate of enrollment. Current enrollment is at 29 patients, with 40 total patients needed for a planned interim analysis. Results from the interim analysis are expected in summer 2012. For a complete list of study sites, please refer to the TEND-TD page on the Medicure website.
"TD remains a significant concern when treating patients with schizophrenia, even with the newer antipsychotics. I am pleased that our facility is participating in this exciting research, and look forward to the interim results," commented Dr. Gary Remington, Director of the Medication Assessment Clinic, Schizophrenia Program, Centre for Addiction and Mental Health; Professor and Schizophrenia Head, Division of Brain and Therapeutics, Department of Psychiatry, University of Toronto; and, principal investigator of the Phase II study.
The Company is also pleased to report that it has received FDA Fast Track designation for the clinical investigation of Tardoxal 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."
This 12-week, randomized, double-blind, placebo-controlled, parallel group comparative study will evaluate the safety and efficacy of Tardoxal in the treatment of TD, a common side effect of antipsychotic medications which are used to treat schizophrenia and schizoaffective disorders. Approximately 4 million people in the United States receive antipsychotic drugs of which approximately 5 to 20% have TD. The primary objective of the Phase II study is to assess the beneficial effect of Tardoxal on the reduction of expressed symptoms of TD compared to placebo. TEND-TD is conducted by Medicure's subsidiary, Medicure International, Inc. Further study information is available at:
About Tardive Dyskinesia
TD is a socially stigmatizing and potentially irreversible long-term disorder caused by treatment with antipsychotic medications which are generally prescribed for conditions such as schizophrenia and schizoaffective disorder. As a neurological disorder, TD has been linked with poor quality of life and increased medical morbidity and mortality. The condition is characterized by repetitive, involuntary, purposeless movements and may include grimacing, tongue protrusion, lip smacking, puckering and pursing of lips, and rapid eye blinking. TD can also lead to unintelligible speech, respiratory distress, postural imbalance, and depression. Management of TD is challenging for the clinician as dose reduction of the prescribed antipsychotic medication may be accompanied by worsening of symptoms or psychotic relapse. Despite extensive research, there are currently no FDA-approved drugs for the management or treatment of TD.
Tardoxal is a naturally occurring, small molecule drug that may have the potential to provide a safe and effective approach to treating patients with TD. Medicure owns intellectual property relating to Tardoxal including its formulation and use in TD. Tardoxal is an experimental drug and has not been approved for commercial use by regulatory bodies such as the FDA or Health Canada.
About Medicure Inc.
Medicure is a specialty pharmaceutical company focused on the development and commercialization of novel small molecule therapeutics. The primary focus of the Company and its subsidiaries is the marketing and distribution of AGGRASTAT® (tirofiban HCl) for acute coronary syndromes in the United States, where it is sold through the Company's US subsidiary, Medicure Pharma, Inc. For more information on Medicure please visit www.medicure.com.
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