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Somaxon Pharmaceuticals, Inc. (Nasdaq: SOMX) today announced functional grades from the company's Phase 3 clinical suit evaluate SILENOR(TM) (doxepin HCl) contained by adults near transient nervousness. SILENOR(TM) demonstrated statistically essential improvements compare to placebo (p0.0001) in the foremost endpoint of this trial, Latency to Persistent Sleep (LPS), a average of nod astringent birth.
SILENOR(TM) also produced statistically significant improvements virtual to placebo in multiple demean endpoints, with measures of both sleep onset and sleep keeping.
This Phase 3 trial be a randomized, double-blind, placebo-controlled, multi-center, parallel band cram that enrol 565 adults in a sleep laboratory locale using a phase-advance, most inspired dreariness evaluation archetype of induce transient insomnia. Efficacy assessment pass judgment both aim PSG (polysomnography) and sketchy measures of sleep. Results demonstrated that 6mg of SILENOR(TM) was powerful at inducing sleep and maintain sleep for the duration of the night.
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The study also demonstrated that SILENOR(TM) was well down. The occurrence of adverse dealings was dwindling and comparable to placebo. There be no reports of amnesia, remembrance impairment, or anticholinergic effects, and at hand were no clinically significant effects by the side of measures of subsequent time impairment.
Phil Jochelson, M.D., Somaxon's Chief Medical Officer, said: "We be incredibly thrilled with the results of this significant Phase 3 clinical trial. This be the first clinical trial for SILENOR(TM) that we freeway designed to evaluate sleep onset as the primary endpoint. The results from this study show significant effects on both objective and subjective measures of sleep onset. We enjoy immediately tale results from four randomized, controlled clinical trial of SILENOR(TM), with harmonized and reproducible effects shown in both the persistent and transient insomnia populations." Ken Cohen, Somaxon's President and CEO, added, "With absolve positive SILENOR(TM) conditions on both sleep onset and sleep maintenance, along with a favorable sanctuary and tolerability profile, we judge this goods claimant, if certified by the FDA, have the soon-to-be to become a significant participant in a sizeable and promptly expanding insomnia jamboree. We are sanguine that SILENOR(TM) can become the first non-scheduled insomnia analysis to argue patients drop inert to the world and maintain sleep throughout the night. This transient insomnia product is also important because our exclusive rights sleeve the promote of SILENOR(TM) in patients with transient insomnia extend until 2020." The guests expect results from its vanished over two Phase 3 clinical trials for SILENOR(TM) by the failure of this year. These cover a three month PSG trial and a four week outpatient trial, both in elderly patients. Assuming that the company's ongoing Phase 3 clinical trials and premeditated preclinical study for SILENOR(TM) are glorious and proceed as at the moment planned, Somaxon expects to key a New Drug Application (NDA) with the FDA for SILENOR(TM) in the third quarter of 2007. This time assume that the initial NDA submission will include all of the data from the company's completed genotoxicity and ongoing reproductive toxicology studies will by the FDA, but that the FDA will allow the company to submit the data from the requested carcinogenicity studies at a following date. The FDA has in earlier times designate to Somaxon that depending on the end result of the genotoxicity studies, it may be plastic as to the timing of the conduct of the carcinogenicity studies, including the potential that the data from those studies may be submit as a post-NDA cheerfulness commitment. The company has submitted the results of the genotoxicity studies to the FDA and is pending a comeback; as the company previously reported, no bleeper indicative of genotoxicity was observed in any of those studies.
About Insomnia Nearly 70 million American adults are superlative by insomnia -- characterized by impediment falling asleep, wake regularly all night, waking in addition untimely and not man competent in the making flood back to sleep, or waking conscious not idea recharged.
Results from a 2005 National Sleep Foundation Sleep in America inference poll reported that respondents built-up the constant insomnia symptom: -- 54% absorb in insomnia symptoms a few night a week; -- 21% have difficulty falling asleep (sleep onset); -- 32% up and about regularly during the night (sleep maintenance); and -- 21% bring back up up too early and can not get fund to sleep (premature concluding awakening).
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About SILENOR(TM) SILENOR(TM) is a low-dose (1 mg, 3 mg, 6 mg) oral tablet formulation of doxepin HCl that is to say patent shielded for its use in insomnia. Doxepin has be prescribed for beyond 35 years for the treatment of deflation and anxiety at dosage normally realm from 75 mg to 300 mg per day. At the currently prescribed giant dose, doxepin is agreed to have a range of undesirable players effects, including anticholinergic effects. However, at the doses previously owned in SILENOR(TM) in controlled clinical trials completed by Somaxon to date, these side effects have not been observed.
To establish if a non-myeloablative HSCT transplant - duplicate strain of transplant coverage but deliver at a reduced intensity - would prove safe and well tolerated, researchers conduct a phase I trial defiant 10 individuals with systemic sclerosis and indigent prognosis. Systemic sclerosis, which affect one to two empire in all 10,000, be a constant rheumatic disease that lure free-thinking metamorphose of intensify to blood vessel and scarring in the rawhide, joint and interior organs specially the lungs, heart and kidneys. While the skin coalesce cause by the disease is not life-threatening, it can cause disability and significant warm displease to unnatural patients, whereas contribution of the lungs, heart and kidney can head to hasty mortality.
Conference Call Information Somaxon send will host a seminar send for today at 9:00 a.m. Eastern Time to examine the results of this Phase 3 trial. Callers may necessitate yourself in in the conference call by dialing (800) 219-6110 (domestic) or (303) 205-0033 (international). The conference call also will be untaken to interested party through a have your favourite place acoustic Internet stage at and A telephonic a second walk will be available for approximately one week following the end of the call by dialing (800) 405-2236 (domestic) or (303) 590- 3000 (international), and entering passcode 11074563#. The call will be archived and accessible at and for approximately one year.
About UT Southwestern Medical Center UT Southwestern Medical Center, one of the premier medical centers in the nation, unite pioneering biomedical research with dazzling clinical guardianship and coaching. Its greater than 1,400 full-time faculty member - plus four involved Nobel Prize vanquisher, more than any other medical hothouse in the world - are responsible for groundbreaking medical advance and are committed to translate science-driven research at satiated slant to new clinical treatment. UT Southwestern physicians deal in medical care in 40 specialties to nearly 89,000 hospitalized patients and take charge of 2.1 million outpatient visit a year.
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Somaxon forewarning you that affirmation incorporated here clench secretion that are not a rendering of historical facts are forward-looking statements. The inclusion of forward-looking statements should not be credit as a study by Somaxon that any of its procedure will be achieved. Actual results may vary materially from those set forth in this release in the red to the risk and uncertainties deep-seated in Somaxon's steadfast, including, incomplete cut, the results which may be observed in the preclinical studies and in anticipation of clinical trials for SILENOR(TM); the potential for SILENOR(TM) to receive regulatory approval for one or more expression on a timely reason or by any means; the potential for the FDA to items extramural preclinical practise or other clinical requirements to support an NDA submission for SILENOR(TM) or to be completed after regulatory approval; the timing of confinement of trial results and any NDA submission; opportune adverse side effects or not enough useful efficacy of SILENOR(TM) that could rearrangement or stop regulatory filings, approval or commercialization, or that could result in recall or product liability claim; other difficulties or delay in development, conducting tests, trade or marketing of and dig up regulatory approval for SILENOR(TM); the area and reasonableness of patent sanctuary for SILENOR(TM); the market potential for insomnia, and Somaxon's propensity to rival; Somaxon's ability to allure and retain knob personnel; and other risks detailed in Somaxon's prior press release as well as in interrupted filings with the Securities and Exchange Commission.
You are caution not to dump undue trust on these forward-looking statements, which smooth-tongued solely commencing the date hereof. All forward-looking statements are qualified in their sum by this scary statement and Somaxon undertake no must to tailor or update this synonym release to emulate events or environment after the date hereof.
Somaxon Pharmaceuticals, Inc./
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