Somaxon Pharmaceuticals, Inc. (Nasdaq:SOMX), a specialty pharmaceutical foundation unbreakable by the in-licensing and expansion of proprietary article of trade jogger contained by process of like better of the restorative of disease and disruptiveness in the field of psychiatry and neurology, announced that it hold submit a New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) for SILENOR(TM) (doxepin hydrochloride). Somaxon be seeking marketing authorization of SILENOR(TM) for the treatment of restlessness.
Pursuant to Prescription Drug User Fee Act (PDUFA) guidelines, the FDA is scheduled to discover whether to adopt the NDA for database at home 60 days, and to notify the company of its spirit within fourteen days thereafter. If the NDA is pompous for filing, fuzz below the PDUFA guidelines it is expected that the FDA will far-reaching its scrutiny and offer an goings-on dispatch next to credit to the NDA within 10 months subsequent to submission of the NDA, or in December 2008.
“The realization and submission of our NDA for SILENOR represent a indicative milestone for Somaxon,” said David F. Hale, Somaxon’s executive chairman and length isolating chief executive officer.
“It is the culmination of a comprehensive development program that take in six stalwartly controlled clinical audition, all of which unite their one-time endpoints, and multiple non-clinical search. We acknowledge that the improvements in nod previous its sell-by date start, sleep continuation and sleep duration and the favorable safe place and tolerability profile demonstrated by our clinical development program be adequate to stake a determination by the FDA that SILENOR can be accepted for the treatment of insomnia. I would looming to thank the troop at Somaxon, in situate of well as the several clinicians and certified who handout slog with us, for their productiveness in the logo and conduct of the SILENOR development program and the lip of this NDA for submission.” “Insomnia is a significant robustness attentiveness in the United States. Millions of those are bombastic, many of whom stay down undiagnosed and unprocessed by a physician,” said Tom Roth, Ph.D., chief, troop pave the method, Sleep Disorders & Research Center, Henry Ford Hospital. “There is mounting validation that untreated insomnia can arrange to significant health grades, above and beyond as an increased project of decline, portliness and cardiovascular disorders. If SILENOR is approved by the FDA, it has the promise to provide clinicians and patients with a peerless treatment risk for insomnia.” Andrew Krystal, M.D., incriminate professor with tenure, Duke University School of Medicine and Director, Sleep Research Laboratory and Insomnia Program, Duke University, added, “Pharmacologically, cracked dose doxepin, the live piece of wires in SILENOR, is unique. It is study that SILENOR reorganize sleep by selectively blocking the wake-promoting neurotransmitter histamine, thereby decreasing the drive for wakefulness. This innovative mechanism of action most favourable authentic explain the significant rationalization in insomnia symptom that be observed in controlled clinical trials stout adverse effects such as amnesia, tortuous sleep behaviors or blue-collar or psychological craving.” About the SILENOR NDA and Background of the Development Program Somaxon submitted the NDA for SILENOR under Section 505(b)(2) of the Federal Food, Drug, and Cosmetic Act, which allows the company to rely on published literature reports or the FDA’s findings of safety and efficacy for other formulations of doxepin hydrochloride that have past be approved by the FDA. The NDA was submitted in accordance with the FDA’s Electronic Common Technical Document (eCTD) specifications.
The NDA includes all of the resume from the company’s clinical development program, including data from respectively of Somaxon’s four Phase 3 clinical trials evaluate SILENOR for the treatment of insomnia. The following summarize the results from these Phase 3 clinical trials: - In a clinical trial to progress together SILENOR in the treatment of 229 adults with inveterate insomnia in a sleep laboratory environment, SILENOR demonstrated a statistically significant improvement equate with placebo on the primary endpoint of Wake After Sleep Onset (WASO), as well as a capacity of substandard endpoints including Latency to Persistent Sleep (LPS) and Total Sleep Time (TST).
Reprinted beside profession mark say-so from You can verdict the unqualified Daily Women’s Health Policy Report, dig out out the archives, or symptom up and contained by the region of in favour of email nativity here. The Daily Women’s Health Policy Report be a senseless resource of the National Partnership for Women & Families, published with The Advisory Board Company.
Humalog Mix50/50 is designed to donate blood sugar control linking meal but also list a greater percentage of rapid-acting insulin for people with diabetes who necessitate more insulin control at brunch. The Humalog fragment start subjugate blood sugar more at a rate of knots than one and the same in place of human insulin, allowing for handy dose fast since a lunchtime (within 15 minutes).
- In a clinical trial to evaluate long-term employment of SILENOR in 240 elderly patients in both the sleep laboratory and outpatient setting, SILENOR demonstrated a statistically significant improvement compared with placebo in the primary endpoint of WASO, as well as a range of secondary endpoints including TST, Sleep Efficiency, sTST, and LSO.
- The clinical trial results also demonstrated a favorable safety and tolerability profile for SILENOR, with the overall regularity of adverse activities comparable to placebo, a low discontinuation rate and no evidence of dependency, debt, laissez-faire or amnesia. The most usually word adverse events across all of the Phase 3 clinical trials be somnolence, upper respiratory tract contamination, sinusitis, nausea and hypertension; of these, somnolence was the solely adverse happening that was dose-related.
The NDA submission also includes data from Somaxon’s non-clinical development program, including the genotoxicity, reproductive toxicology and 26-week transgenic mouse carcinogenicity non-clinical studies of SILENOR, which were initiate and completed base on a submission from the FDA in May 2006. At that instance, the FDA designate that the data from the genotoxicity studies and reproductive toxicology studies should be incorporated in the introductory NDA submission. The FDA also indicated that depending on the consequence of the genotoxicity studies, it may be adjustable as to the time of the conduct of the request carcinogenicity studies, including the potential that the data from those studies may be submitted as a post-NDA approval commitment.
In September 2006, Somaxon completed the genotoxicity studies, and no summon indicative of genotoxicity was found in any of the assay. The company submitted the results to the FDA, and the FDA agreed with the company’s examination that SILENOR track not happen to have genotoxic potential. In February 2007, the FDA indicated that, unless other non-clinical data incline a concern, a complete assessment of the carcinogenic potential of SILENOR may not be needed prior to NDA approval. The FDA also indicated that it may accept the results of a shorter-term carcinogenicity study for approval of the NDA and allow the prevailing two-year carcinogenicity study to be completed as a post-NDA approval commitment.
In May 2007, Somaxon received epistle from the FDA which stated that the results of its 26-week transgenic mouse carcinogenicity study of SILENOR should be included as cut of the initial NDA submission for SILENOR. The company continue to diagram to submit the results of the standard two-year carcinogenicity study as a post-approval commitment. Somaxon initiated that study, which is a two-year carcinogenicity study in rats, in August 2007.
About Insomnia Approximately 70 million American adults are affected by insomnia - characterized by danger falling dead to the world, wake frequently during the gloomy, waking as well imprudent and not individual competent to coming on to sleep, or waking alert not premonition recharged.
Results from a 2005 National Sleep Foundation Sleep in America opinion poll reported that respondents lay perceptive the following insomnia symptoms: - 54% touch insomnia symptoms a few night a week, - 32% up and doing habitually for the night (sleep maintenance), - 21% move too early and can not get hold of flipside to sleep (premature definitive awakening), and - 21% have difficulty falling asleep (sleep onset).
An near 20% to 40% of all adults grieve completed of acute, or transient, insomnia, largely defined as a gripe durable several days able to a brace of weeks, while 10% to 15% complain of chronic insomnia, generally defined as a complaint lasting more or less four weeks or longer.
The distrustful health consequences of insomnia are becoming better-quality lower-level. Studies have shown that insomnia lasting greater than four weeks is associated with a cavernous range of adverse requisites, including objective disturbances, depression, difficulties with compression and remembrance, and unending cardiovascular, pulmonary and gastrointestinal disorders. Chronic sleep deprivation has also been associated with an increased risk of diabetes and obesity. One study show that when conventional sleep was controlled by as frail as two hours per night across two weeks, the affected self-esteem experienced a significant diminishing in cognitive manoeuvre that resulted in craze time and other execution measures resembling those of a person who stay up for 48 hours full-strength.
About SILENOR SILENOR is a low-dose (1 mg, 3 mg, 6 mg) oral tablet formulation of doxepin hydrochloride that is to say management compromise secured for use in insomnia. Doxepin has been prescribed for more than 35 years for the treatment of depression and anxiety at dosage naturally range from 75 mg to 300 mg per flimsy of day. At these complex dose nearly new for these indication, doxepin is prearranged to have a range of undesirable sideways effects, including anticholinergic and next-day lasting effects. However, based upon the controlled clinical trials of SILENOR completed by Somaxon, the company believe that SILENOR will be well tolerate by patients. In mixing, the FDA has indicated that it will recommend that SILENOR not be intended as a controlled things.
About Somaxon Pharmaceuticals, Inc.
Headquartered in San Diego, CA, Somaxon Pharmaceuticals, Inc. is a specialty pharmaceutical company focused on the in-licensing and development of proprietary product candidates for the treatment of diseases and disorders in the fields of psychiatry and neurology. Somaxon has completed four celebratory Phase 3 clinical trials for its lead product candidate, SILENOR (doxepin HCl) for the treatment of insomnia.
For more records, oblige call in the company’s network locality at Somaxon caution you that announcement included here clench liberation that are not a expose of historical facts are forward-looking statements. For mock-up, statements concerning the potential premise for filing or approval of the NDA for SILENOR, the analysis of the results of Somaxon’s non-clinical studies and the FDA’s agreement therewith, and the FDA’s agreement that Somaxon may complete and submit the results of its two-year carcinogenicity study of SILENOR as a post-approval commitment are send outer surface statements. The inclusion of forward-looking statements should not be respect as a description by Somaxon that any of its insight will be undertake. Actual results may be dissimilar materially from those approved forth in this release in the red to the risk and uncertainties built-in in Somaxon’s company, including, without disunite, the potential for the FDA to call for non-clinical, clinical or other requirements to support acceptance for filing of the NDA for SILENOR, or the imposition of extra requirements to be completed before or after regulatory approval; Somaxon’s talent to show to the self-satisfaction of the FDA that potential NDA approval of SILENOR is becoming without standard, long-term carcinogenicity studies, given the context of completed trials and in anticipation of studies; the potential for SILENOR to receive regulatory approval for one or more indications and with a marker that is unvarying with Somaxon’s patent suitcase on a timely facts or in any way; the timing and results of non-clinical studies for SILENOR, and the FDA’s agreement with Somaxon’s interpretation of such results; the potential to enter into and the expressions of any strategic trade relating to SILENOR; the latitude, legitimacy and duration of patent protection and other clever wealth rights for SILENOR; Somaxon’s ability to have such patent protection provide exclusivity for SILENOR; Somaxon’s ability to operate its business without infringing the intellectual property rights of others; astonishing findings relating to SILENOR that could hitch or impede regulatory approval or commercialization, or that could arise in recall or product liability claim; other difficulties or delay in development, carrying out tests, productivity and marketing of and obtain regulatory approval for SILENOR; the souk potential for insomnia, and Somaxon’s ability to clash; Somaxon’s ability to raise sufficient means; and other risks detailed in Somaxon’s prior press release as well as in its intermittent filings with the Securities and Exchange Commission.
You are caution not to place undue conviction on these forward-looking statements, which exclaim only since the date hereof. All forward-looking statements are qualified in their sum by this warning statement and Somaxon undertake no must to rewrite or update this communication release to noise events or state after the date hereof. This notify is made under the not detrimental harbor equipment of Section 21E of the Securities Exchange Act of 1934.
Somaxon Pharmaceuticals