Date: 2017-07-11
Type of
information: Publication of results in a medical journal
phase: 3
Announcement: publication of results in JAMA Neurology
Company: Teva Pharmaceutical Industries (Israel)
Product: Austedo™ (SD-809 - deutetrabenazine)
Action
mechanism:
- protein inhibitor/VMAT2 inhibitor. SD-809 (deutetrabenazine) is a small molecule inhibitor of vesicular monoamine 2 transporter, or VMAT2, that is designed to regulate the levels of dopamine in the brain. SD-809 is being developed for the treatment of chorea associated with Huntington’s disease. SD-809 (deutetrabenazine) is Auspex Pharmaceuticals's lead investigational product.
- SD-809 became part of Teva’s central nervous system (CNS) product portfolio with the acquisition of Auspex Pharmaceuticals in May 2015.
Disease: chorea associated with Huntington disease
Therapeutic
area: Neurodegenerative diseases - Rare diseases
Country:
Trial
details:
- 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.
Latest
news:
- • On July 11, 2017, Teva Pharmaceutical Industries and the Huntington Study Group 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 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 .
Is
general: Yes
