Tardoxal™ is a naturally occurring, small molecule drug that is in development for a neurological condition known as Tardive Dyskinesia (TD). Tardoxal has demonstrated activity on a number of biological factors believed to be responsible for TD. Medicure has conducted extensive research and development activity with the molecule and established its safety profile in clinical trials enrolling over 4,000 patients. Based on preliminary results of its Phase IIa Clinical Trial, Tardoxal™ for the Treatment of Tardive Dyskinesia (TEND-TD), Medicure is developing a modified formulation as a prelude to a larger, confirmatory Phase II study.
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 Tardive Dyskinesia.
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: clinicaltrials.gov
Tardoxal is an experimental drug and is not approved by the FDA.