Teva Pharmaceuticals announced that the phase 2/3 ARTISTS 1 and phase 3 ARTISTS 2 trials of deutetrabenazine in pediatric patients with moderate to severe Tourette Syndrome did not meet the primary end point.
ARTISTS 1 and ARTISTS 2 are phase 3, multicenter, randomized, double-blind, placebo-controlled studies that assessed the efficacy and safety of deutetrabenazine in 277 pediatric patients aged 6 to 16 years with moderate to severe Tourette Syndrome. Patients were randomized 1:1 to receive either deutetrabenazine or placebo for 8 weeks (ARTISTS 2) or 12 weeks (ARTISTS 1). The primary end point for both studies was the change in the Total Tic Score of the Yale Global Tic Severity Scale (YGTSS-TTS).
Findings from both studies demonstrated that deutetrabenazine failed to meet the primary end point of reduction in motor and phonic tics. To date, the most commonly reported adverse events were headache, somnolence and fatigue. The safety profile of deutetrabenazine was consistent with that seen in previous studies and no new safety signals were identified.
“The results of the trials are disappointing, especially as there is such an unmet need for this community of pediatric patients,” said Dr. Hafrun Fridriksdottir, Executive VP, Global R&D, at Teva. “As we assess a path forward, Teva is especially grateful to the investigators, patients and families who contributed to these studies for such an important patient population.”
Deutetrabenazine, a vesicular monoamine transporter 2 (VMAT2) inhibitor, is marketed under the brand name Austedo and is currently approved for the treatment of tardive dyskinesia in adults and for the treatment of chorea associated with Huntington disease.
For more information tevapharm.com.