Navigation Links
Synosia Starts Phase II Efficacy Trial For Rufinamide
Date:3/31/2008

Epilepsy Drug to be Tested as Treatment for Anxiety

Synosia Therapeutics today announced the start of a multi-site, Phase II clinical trial to evaluate the efficacy of rufinamide (SYN-111), a sodium channel blocker, as a potential treatment for general anxiety disorder.

BASEL, Switzerland, March 31 /PRNewswire/ -- The trial is an eight-week, double-blind, placebo-controlled, exploratory study being conducted in 20 sites in the United States. It will assess the efficacy and tolerability of rufinamide in up to 230 patients with general anxiety disorder, as measured by multiple psychometric assessment tools. Patients randomized to rufinamide will receive 250mg twice a day for one week followed by 500mg twice a day for seven weeks. The trial design was guided by the encouraging results of a proof-of-concept study announced in January 2008.

Rufinamide was discovered and developed by Novartis. Rights to SYN-111 were obtained by Synosia from Novartis in 2007 in an exclusive worldwide licensing agreement, outside of Japan, to develop and commercialize rufinamide for the treatment of anxiety and other mood disorders. Rufinamide is also marketed by Eisai in Europe as a drug to treat a form of epilepsy under the tradename Inovelon(R).

"Given the extensive safety experience available from previous studies, we believe this structurally novel compound has the potential to relieve anxiety without the adverse side effects of current treatments," said Stephen Bandak, Synosia's chief medical officer. "There is a real need for new treatment options without the limited compliance associated with selective serotonin reuptake inhibitors (SSRIs) or the risk of dependence of benzodiazepine-based treatments."

It is estimated that over 62 million people in the United States and the five major European pharmaceutical markets 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 certain 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 therapy in Lennox-Gastaut Syndrome (LGS), a severe form of epilepsy that develops in early childhood. The extensive clinical development program for rufinamide in epilepsy has generated over 2500 patient years of exposure to the drug.

About Synosia Therapeutics

Synosia Therapeutics develops and intends to commercialize innovative and clinically differentiated products for unmet medical needs in psychiatry and neurology. The privately-owned company has six clinical-stage compounds in its pipeline, acquired through key partnerships with Novartis, Roche and Syngenta. Synosia's pipeline includes two marketed drugs that will be tested in new indications, extending their reach into neurological and psychiatric diseases with high unmet medical need, including anxiety and Parkinson's Disease. Synosia's headquarters is in Basel, Switzerland. For more information visit http://www.synosia.com

Disclaimer

This communication expressly or implicitly contains certain forward-looking statements concerning Synosia Therapeutics and its business. Such statements involve certain known and unknown risks, uncertainties and other factors which could cause the actual results, financial condition, performance or achievements of Synosia Therapeutics to be materially different from any future results, performance or achievements expressed or implied by such forward-looking statements.

Synosia Therapeutics is providing this communication as of this date and does not undertake to update any forward-looking statements contained herein as a result of new information, future events or otherwise.

References

(1) Demyttenaere et al. Prevalence, Severity, and unmet needs for treatment of mental disorders in the WHO World Mental Surveys. JAMA (2004) vol. 291 (21) pp. 2581-90.

(2) Kessler et al. Lifetime prevalence 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.


'/>"/>
SOURCE Synosia Therapeutics
Copyright©2008 PR Newswire.
All rights reserved

Related biology technology :

1. Synosia Therapeutics Announces Appointment of Chief Business Officer
2. Synosia Announces Encouraging Results of Proof-of-Concept Clinical Trial for Epilepsy Drug rufinamide as a Treatment for Mood Disorders
3. Synosia Therapeutics Appoints Chief Financial Officer to New Company Headquarters in Switzerland
4. Carrington Subsidiary DelSite Starts Making Test Batches of First Bird Flu Vaccine Offering Needle-free Self-Administration
5. Evotec Starts Phase II in Smoking Cessation with EVT 302
6. Dendreon Announces Publication of Phase 1 Study Highlighting Immunologic and Clinical Activity of Lapuleucel-T (Neuvenge(R)) in Advanced Breast Cancer Patients
7. The Multiple Myeloma Research Consortium (MMRC) and Proteolix Initiate Phase 2 Clinical Trial Investigating Carfilzomib for the Treatment of Multiple Myeloma
8. Vion Pharmaceuticals Completes Accrual of 85 Patients to its Pivotal Phase II Trial of Cloretazine(R) (VNP40101M) in Elderly AML
9. ONCOSCIENCE AG, THE EUROPEAN PARTNER OF YM BIOSCIENCES, ANNOUNCES COMPLETION OF PATIENT ENROLLMENT IN PHASE III BRAIN CANCER TRIAL OF NIMOTUZUMAB
10. Evotec to Present Details of the Positive Phase II Study in Insomnia With EVT 201 at the Worldsleep07 Congress in Cairns/Australia
11. Phase III Trial Finds Pharmaxis Bronchitol Effective
Post Your Comments:
*Name:
*Comment:
*Email:
(Date:6/23/2016)... ... June 23, 2016 , ... Charm ... Mold) microbial test has received AOAC Research Institute approval 061601. , “This is ... last year,” stated Bob Salter, Vice President of Regulatory and Industrial Affairs. “The ...
(Date:6/23/2016)... -- The Biodesign Challenge (BDC), a university competition that asks ... systems and biotechnology, announced its winning teams at the ... York City . The teams, chosen ... MoMA,s Celeste Bartos Theater during the daylong summit. Keynote ... of architecture and design, and Suzanne Lee , ...
(Date:6/23/2016)... ... June 23, 2016 , ... Supplyframe, the Industry ... Supplyframe Design Lab . Located in Pasadena, Calif., the Design Lab’s mission ... hardware projects are designed, built and brought to market. , The Design Lab ...
(Date:6/23/2016)... ... , ... In a new case report published today in STEM CELLS Translational ... lymphedema after being treated for breast cancer benefitted from an injection of stem cells ... this debilitating, frequent side effect of cancer treatment. , Lymphedema refers to ...
Breaking Biology Technology:
(Date:6/1/2016)... June 1, 2016 Favorable Government ... Administration and Criminal Identification to Boost Global Biometrics System ... released TechSci Research report, " Global Biometrics Market ... Forecast and Opportunities, 2011 - 2021", the global biometrics ... 2021, on account of growing security concerns across various ...
(Date:5/12/2016)... 12, 2016 WearablesResearch.com , a brand ... overview results from the Q1 wave of its quarterly ... was consumers, receptivity to a program where they would ... health insurance company. "We were surprised to ... Michael LaColla , CEO of Troubadour Research, "primarily ...
(Date:4/28/2016)... -- First quarter 2016:   , Revenues ... first quarter of 2015 The gross margin was 49% ... and the operating margin was 40% (-13) Earnings per ... from operations was SEK 249.9 M (21.2) , Outlook ... 7,000-8,500 M. The operating margin for 2016 is estimated ...
Breaking Biology News(10 mins):