Data support overnight conversion from tetrabenazine to AUSTEDO™ for the treatment of chorea associated with Huntington disease
JERUSALEM–(BUSINESS WIRE)–Jul. 11, 2017– Teva Pharmaceutical Industries Ltd. (NYSE and TASE:TEVA) and the Huntington Study Group today announced results from the Phase III open-label, single-arm switch cohort of the ARC-HD (Alternatives for Reducing Chorea in HD) study were published in JAMA Neurology. Results from the study showed patients with chorea associated with Huntington disease (HD) were able to safely switch overnight from three times daily tetrabenazine to twice daily AUSTEDO™ (deutetrabenazine) tablets. The ARC-HD study was conducted by Teva in partnership with the Huntington Study Group.
A rare and fatal neurodegenerative disorder, HD affects approximately 35,000 people in the United States. Chorea – involuntary, random and sudden, twisting and/or writhing movements – is one of the most striking physical manifestations of this disease and occurs in approximately 90% of patients. HD may also manifest as cognitive deterioration and behavioral and/or psychological problems.
“Chorea is a debilitating symptom of Huntington disease that can impact the safety, function and quality of life of many patients,” said Michael Hayden, M.D., Ph.D., President of Global R&D and Chief Scientific Officer at Teva. “We are pleased to share the ARC-HD study results to allow those physicians treating HD patients to increase their knowledge of AUSTEDO™.”
“Human-based research is critical to evolving our understanding of HD and to providing more options and meaningful treatments,” said Samuel Frank, M.D., principal investigator of the ARC-HD study and Director of the Huntington’s Disease Society of America Center of Excellence at Beth Israel Deaconess Medical Center. “It could not be done without the dedication of patients and their families who participate in clinical trials, for which we are extremely grateful.”
The ARC-HD study enrolled 37 patients who had been on a stable tetrabenazine regimen (≥8 weeks). Patients were converted from tetrabenazine to an initial AUSTEDO™ daily dose of approximately half the prior tetrabenazine daily dosage. One week after overnight conversion to AUSTEDO™, investigators could begin weekly dose adjustments, if needed, to achieve optimal chorea control. Changes from baseline in United Huntington’s Disease Rating Scale (UHDRS), Total Maximal Chorea Score (TMC) and Total Motor Score (TMS) were evaluated as efficacy endpoints.
For more information regarding this JAMA Neurology publication, visit http://jamanetwork.com/journals/jamaneurology/fullarticle/2643174.
Source: Pharmaceutical Industries Ltd