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
Buy diflucan pills Basel, Switzerland. For more information visit
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.
Synosia Therapeutics
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