The try-out be an eight-week, double-blind, placebo-controlled, exploratory office self conduct contained by 20 position in the United States. It will review the efficacy and tolerability of rufinamide in proficient of 230 patients beside standard anxiety bedlam, through measured with multiple psychometric evaluation tools. Patients randomized to rufinamide will receive 250mg two times a morning all for one week follow by 500mg twice a day for seven weeks. The trial shape be radar apparatus by the encouraging grades of a proof-of-concept study announced in January 2008.
Rufinamide was discovered and preset by Novartis. Rights to SYN-111 be attain by Synosia from Novartis in 2007 in an superlative macro license agreement, outer surface of Japan, for the future along and commercialize rufinamide for the rehabilitation of anxiety and other sense disorder. Rufinamide is also flea market by Eisai in Europe as a pills to luxury a contour of epilepsy down below the tradename Inovelon(R).
"Given the across-the-board haven go through going spare from prior study, we feel this structurally new-fangled combination have the eventual to agree to go anxiety in need the adverse against the side effects of contemporary treatment," said Stephen Bandak, Synosia's chief medical officer. "There is a authentic stipulation for trial treatment selection without the controlled agreement associated with selective serotonin reuptake inhibitors (SSRIs) or the chance of craving of benzodiazepine-based treatments." It is near that over and done with 62 million those in the United States and the five highest European pharmaceutical market suffer from a form of anxiety. Of those, over nine million suffer from general anxiety disorder.(1),(2) About Rufinamide The drug was originally discovered and developed by Novartis, which in 2004 granted true licensing rights to Eisai, excluding anxiety and mood disorders. In January 2007, Eisai received marketing authorisation in the European Union for Inovelon(R) (rufinamide) as adjunctive anti-epileptic analysis in Lennox-Gastaut Syndrome (LGS), a unbending form of epilepsy that develop in precipitate shaping years. The extensive clinical advancement program for rufinamide in epilepsy has generate over 2500 long-suffering years of revealing to the drug.
About Synosia Therapeutics Synosia Therapeutics develops and intend to commercialize revolutionary and clinically differentiate products for unmet medical requests in psychiatry and neurology. The privately-owned ensemble has six clinical-stage compound in its pipeline, acquire through knob partnership with Novartis, Roche and Syngenta. Synosia's pipeline include two marketed drugs that will be tested in new indication, extend their annihilate into neurological and psychiatric bug with capacious unmet medical need, together with anxiety and Parkinson's Disease. Synosia's headquarters is in Basel, Switzerland. For more hearsay stop by Disclaimer This communication expressly or implicitly comprise certain forward-looking statement about Synosia Therapeutics and its company. Such statements confuse with certain certain and unknown risk, uncertainties and other factor which could wreak the actual results, fiscal situation, engaged or achievement of Synosia Therapeutics to be materially nothing like from any anticipated results, performance or achievements expressed or implied by such forward-looking statements.
Synosia Therapeutics is providing this communication starting this date and do not embark upon to update any forward-looking statements contained herein thus of new information, future dealings or otherwise.
References (1) Demyttenaere et al. Prevalence, Severity, and unmet needs for treatment of psychosomatic disorders in the WHO World Mental Surveys. JAMA (2004) vol. 291 (21) pp. 2581-90.
(2) Kessler et al. Lifetime predominance and age-of-onset distributions of DSM-IV disorders in the National Comorbidity Survey Replication. Arch Gen Psychiatry (2005) vol. 62 (6) pp. 593-602.
Synosia Therapeutics
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