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The approval was based in part on the results of two 12-week, randomized, double-blind, placebo-controlled, multicenter trials, which compared changes in involuntary movements in 335 patients with TD who took deutetrabenazine or placebo. A total of 62% of the patients had concurrent diagnoses of schizophrenia/schizoaffective disorder, and 33% had a mood disorder; 86% were receiving concomitant antipsychotics.
For the first trial, 222 patients aged 21 to 81 were randomly assigned to deutetrabenazine (12 mg/day, 24 mg/day, 36 mg/day) or placebo. Two dosage levels—24 mg/day and 36 mg/day—were associated with statistically significant improvement in patients’ Abnormal Involuntary Movement Scale (AIMS) score, from baseline to week 12, compared with placebo.
For the second trial, 113 patients aged 25 to 75 received daily doses of placebo or deutetrabenazine, starting at 12 mg/day, with titration up to 48 mg/day over a six-week period. This was followed by a six-week maintenance period at an average dose of 38.3 mg/day. From baseline to week 12, the AIMS total score decreased significantly in patients receiving deutetrabenazine compared with those receiving placebo.
“We are pleased to bring forward this second indication for Austedo to treat the underserved tardive dyskinesia population,” Michael Hayden, M.D., Ph.D., president of Global R&D and chief scientific officer at Teva, said in a Teva press release. “We believe physicians treating tardive dyskinesia will appreciate the therapy’s dosing flexibility and the ability to focus on directly treating the movement disorder and not disrupt the ongoing treatment for the underlying condition.”
According to Teva, the most common adverse effects reported by patients taking Austedo were nasopharyngitis and insomnia.
For more information, see the Psychiatric News PsychoPharm article “New Hope for Patients With Tardive Dyskinesia” by Stanley N. Caroff, M.D.