Drugs

Teva Plans NDA for Tardive Dyskinesia Drug

Teva Pharmaceutical Industries has reported statistically significant results in a second Phase 3 registration trial involving SD-809 (deutetrabenazine) and its use for treating tardive dyskinesia. Teva expects to submit an NDA by the end of the year.

In the AIM-TD trial, the primary endpoint was change in Abnormal Involuntary Movement Scale (AIMS) score from baseline to week 12 for three fixed doses of SD-809 as compared to placebo, according to the company. Patients’ abnormal movements were assessed by blinded central video rating. “All doses improved AIMS scores compared to placebo and at week 12, the 24 mg and 36 mg dose groups of SD-809 demonstrated a significant change from baseline based on the modified intent-to-treat population,” it says.

Tardive dyskinesia is a hyperkinetic movement disorder characterized by repetitive and uncontrollable movements of the tongue, lips, face, trunk and extremities. The disorder affects about 500,000 people in the U.S. and is caused by medications used to treat psychiatric conditions such as schizophrenia and bipolar disease.

In June, FDA issued Teva a Complete Response Letter on a separate NDA for SD-809 for treating chorea-associated Huntington disease. The agency has asked Teva to examine blood levels of certain metabolites, according to the company. “These metabolites are not novel, and are the same seen in subjects who take tetrabenazine or deutetrabenazine,” it says, adding that no new clinical trials have been requested. A response to FDA is being planned for this quarter.

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Gupta Raises Concerns About Overton’s Independence, Ideology

Overton Confirmation Remains Uncertain After Senate Hearing

FDA Classifies Boston Scientific Imager II Catheter Recall as Class I

FDA Approves Gazyva for Childhood-Onset Idiopathic Nephrotic Syndrome