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Tardoxal

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. The product is currently being evaluated in a Phase II proof-of-principle clinical study.

About Tardive Dyskinesia

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 Clinical Trial (Phase II)

TEND-TD is a 12-week, randomized, double-blind, placebo-controlled, parallel group comparative study that will evaluate the safety and efficacy of Tardoxal in the treatment of Tardive Dyskinesia (TD), a common side effect of antipsychotic medications which are used to treat schizophrenia and schizoaffective disorders. 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 being conducted by Medicure's subsidiary, Medicure International, Inc. Further study information is available at www.ClinicalTrials.gov.

Tardoxal is an experimental drug and is not approved by the FDA.