Tetrabenazine is a highly selective and reversible centrally-acting dopamine depleting drug that works by inhibiting a molecule known as vesicular monoamine transporter 2 (VMAT2). Xenazine was approved by the FDA on August 15, 2008, for the treatment of chorea associated with Huntington's disease, based on the results of a double-blind, placebo-controlled, Phase 3 study that found Xenazine significantly reduced patients' chorea burden, improved global outcome scores, and was generally safe and well tolerated. Additional post-marketing preclinical studies further elucidating the safety profile of the product are being conducted. Tetrabenazine has been available in Europe for more than 30 years and in Canada since 1996.
People with Huntington disease (HD) experienced improvements in chorea while taking deutetrabenazine (SD-809) compared to placebo, according to a paper published today in the Journal of the American Medical Association.
Treatment with a deuterated form of tetrabenazine has resulted in improved motor signs among patients with Huntington disease, making it a potential treatment for chorea, trial findings show.
Living Cell Technologies Limited today announced results from a Phase I/IIa clinical study of NTCELL, an experimental regenerative cell therapy being studied as a disease-modifying agent in Parkinson’s disease. The study, conducted in four patients in New Zealand, met its primary endpoint of safety, showing NTCELL implantation was well tolerated, with no adverse events considered to be related to NTCELL.
Omeros Corporation today announced dosing of the first patient in a second Phase 2 clinical trial of OMS824, the company's phosphodiesterase 10 (PDE10) inhibitor being developed for the treatment of schizophrenia, Huntington's disease (HD) and other cognitive disorders. The Phase 2 trial will evaluate the tolerability, safety, pharmacokinetics and performance on a battery of tests in patients with symptomatic HD.
Although drugs have been developed that inhibit the imbalance of neurotransmitters in the brain - a condition which causes many brain disorders and nervous system diseases - the exact understanding of the mechanism by which these drugs work has not yet been fully understood.
Omeros Corporation announced that OMS824, its phosphodiesterase 10 inhibitor, has received orphan drug designation from the U.S. Food and Drug Administration for the treatment of Huntington's disease.
Auspex Pharmaceuticals announced today that the first patient has been enrolled in a multi-center Phase 3 pivotal trial of its lead investigational drug, SD-809 for the treatment of involuntary movements (chorea) associated with Huntington's Disease.
The Huntington Study Group (HSG), under the leadership of Samuel Frank, MD, Principal Investigator, (Boston University School of Medicine) and Claudia Testa, MD, PhD, co-Principal Investigator (Virginia Commonwealth University), is conducting a clinical trial with a formulation of the novel drug SD-809 in the treatment of HD the United States and Canada.
Omeros Corporation today announced that its Investigational New Drug Application to evaluate OMS824 in Huntington's disease has been cleared by the U.S. Food and Drug Administration.
Teva Pharmaceutical Industries Ltd announced today that it has concluded an Asset Transfer Agreement with NeuroSearch A/S of Denmark to purchase all rights, assets and obligations relating to Huntexil (pridopidine / ACR16), a drug candidate being developed for the symptomatic treatment of hand movement, balance and gait disturbances in Huntington disease (HD).
A new guideline released by the American Academy of Neurology recommends several treatments for people with Huntington's disease who experience chorea—jerky, random, uncontrollable movements that can make everyday activities challenging.
Biovail Corporation today announced financial results for the three-month and six-month periods ended June 30, 2010.
Biovail Corporation today announced its financial results for the three-month period ended March 31, 2010.
Lundbeck Inc. today announced the presentation of results from an open-label extension study of Xenazine- (tetrabenazine) for the treatment of chorea associated with Huntington's disease (HD). Data from this study demonstrated that after an 80-week treatment period, subjects treated with Xenazine experienced a statistically significant reduction in chorea score (p< 0.0001) as measured using the Unified Huntington's Disease Rating Scale (UHDRS) compared with baseline.
Biovail Corporation today announced financial results for the three-month and 12-month periods ending December 31, 2009.
A medication previously studied in patients with Alzheimer's disease (latrepirdine) appears well tolerated and may improve thinking, learning and memory skills among individuals with Huntington's disease, according to a report in the February issue of Archives of Neurology, one of the JAMA/Archives journals.
Biovail Corporation today announced financial results for the three-month and nine-month periods ended September 30, 2009. To the extent that this news release contains forward-looking statements, investors are cautioned that these statements are based on the Company’s current views, and actual outcomes are not certain.
Biovail Corporation today announced a wholly owned subsidiary has entered into a definitive agreement to acquire worldwide development and commercialization rights to the entire portfolio of tetrabenazine products, including Xenazine/Nitoman (tetrabenazine tablets), and the associated intellectual property rights held by Cambridge Laboratories (Ireland) Ltd and its affiliates.
Cambridge Laboratories Limited has announced that its flagship product Tetrabenazine, (known as NITOMAN in Germany and other key European territories and XENAZINE in the UK, U.S. and other markets) has received marketing approval in Spain from the Agencia Espanola de Medicamentos y Productos Sanitarios.
Huntington's disease is a fatal, inherited neurodegenerative disorder for which there is no cure and usually affects people in their 30s and 40s, but some patients are affected as early as childhood, while others aren't affected until they are older.