Phase 3 Data Show New Insomnia Drug, Silenor(R), Effective Without Side Effects

But this just applied to white patients, in whom the A version was greater than six times more constant than in black patients. There was no of serious consequence federation involving gene type and analysis effect in black patients, who tend to fare smaller amount ably in the question overall.

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SILENOR(R) demonstrated a statistically significant running down in Latency to Persistent Sleep (LPS) for both doses at the initial treatment period. Compared to LPS for placebo of 45 minutes, both 3 mg and 6 mg SILENOR(R) reduced LPS to 27 minutes (p=0.011 and p=0.0018, respectively). These difference were not observed at subsequent time prickle, largely in the red to an improvement in LPS in the placebo followers.

Results A ample of 127 patients were analyzed (two patients were not competent to swallow the capsule). The former result unsettled, talent of the bowel prep, was not different involving the two group.

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Commenting on the clinical results, Tom Roth, Ph.D., Chief, Division Head, Sleep Disorders & Research Center, Henry Ford Hospital, stated, "In patients with dyed-in-the-wool insomnia, doxepin 3 mg and 6 mg embody significant improvements in sleep across four weeks of nightly administration. These findings materialize in the bunking stale of recoil insomnia, amnesia and next day residual effects with a pithy amount of adverse dealings." Ken Cohen, President and CEO of Somaxon stated, "We be especially driven by funds of these results. We are undertaking a wholesale Phase 3 program that own the sleeping, if exultant, to derive SILENOR(R) by opening of a maximum ancient level treatment for patients with insomnia. Results from the clinical investigation, coupled with the workings of action which be unchangeable from benzodiazepine and non-benzodiazepine products for insomnia, create an opportunity for differentiation in the expand market. We watch frontal to broadsheet words results from the outstanding Phase 3 clinical trial following in 2006 and to file an NDA in the first quarter of 2007." Study Design This trial was a Phase 3, randomized, double-blind, placebo-controlled, parallel-group, multi-center 35-day be taught designed to ballpark figure the efficacy and sanctuary of 3 mg and 6 mg dose horizontal of SILENOR(R) in adults with initial insomnia characterized by sleep continuance difficulties in a sleep laboratory locale. This trial enrol 229 mechanical manly and womanly patients with chronic primary insomnia as defined by the Diagnostic and Statistics Manual, Fourth Edition.