Epilepsy Drug to be Tested as Treatment for Anxiety
BASEL, Switzerland, March 31 /CNW/ - 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.
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
"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
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)
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
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
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forward-looking statements concerning Synosia Therapeutics and its business.
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other factors which could cause the actual results, financial condition,
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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.
(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.
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