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Teva Pharmaceutical Industries Ltd. (NYSE:TEVA) said two doses of SD-809 deutetrabenazine met the primary endpoint in the Phase III AIM-TD study to treat moderate to severe tardive dyskinesia. The company intends to submit an NDA to FDA for SD-809 by year end.
The 288-patient trial evaluated 12, 24 and 36 mg doses of SD-809 vs. placebo, and measured improvements in Abnormal Involuntary Movement Scale (AIMS) from baseline to 12 weeks. The high and middle doses improved baseline scores by 3.3 and 3.2 points, respectively, vs. 1.4 points for placebo (p=0.001 for the high dose and p=0.003 for the middle dose). The low dose improved scores by 2.1 points, which was non-significant vs. placebo.
Teva said the frequency of adverse events was similar among all treatment groups, and said SD-809's safety profile was consistent with previous studies.
In June 2015, SD-809 met the primary endpoint of improving AIMS scores in the Phase II/III ARM-TD study to treat moderate to severe tardive dyskinesia (see BioCentury Extra, June 16, 2015).
SD-809 is a deuterium-substituted analog of tetrabenazine, a vesicular monoamine transporter 2 (VMAT2; SLC18A2) inhibitor. Teva gained the candidate via its May 2015 acquisition of Auspex Pharmaceuticals Inc. (see BioCentury, April 6, 2015).
SD-809 has breakthrough therapy designation for tardive dyskinesia. It has Orphan Drug designation in Huntington's disease (HD) and Tourette's syndrome in patients aged 16 and younger. In May, Teva received a complete response letter from FDA for SD-809 to treat chorea associated with HD. Spokesperson Doris Saltkill said the company plans to respond to FDA this quarter on the CRL (see BioCentury Extra, May 31).
An NDA for competing VMAT2 inhibitor Ingrezza valbenazine (NBI-98854) from Neurocrine Biosciences Inc. (NASDAQ:NBIX) is under FDA review to treat tardive dyskinesia. Last year, Neurocrine said an 80 mg dose of Ingrezza significantly improved AIMS scores by 3.1 points more than placebo from baseline to six weeks, meeting the primary endpoint in a Phase III study's intent-to-treat population (see BioCentury Extra, Oct. 8, 2015).
Original Article: Teva's SD-809 passes latest tardive dyskinesia testNEXT ARTICLE
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