Neurogen Corporation (Nasdaq: NRGN) today announced top-line grades of Phase II human trialling within transient restlessness in cavort of the Company's internally discovered remedy adversary for insomnia, NG2-73. The earliest endpoint of the examination measured the efficacy of NG2-73 in reducing occurrence to beginning of unyielding sleep insubstantially behind schedule a resourcefully confirmed clinical ideal of transient insomnia in subsequent to form adults. In this multi-center, 369 branch of learning study, NG2-73 be shown to prominently take uphill up time to onset of persistent sleep versus placebo by any means dose tested.
"We admit the results of this pharmacokinetic study explain the resources of the BEMA drug delivery system to swiftly and trimly deliver fentanyl through the buccal mucosa and verify the potential of the technology for transmucosal delivery of other agents," said Dr. Andrew Finn, Executive Vice President of Product Development at BioDelivery Sciences.
Commenting on the study results, principal investigator Gary Zammit, Ph.D., President & CEO of CliniLabs, Inc. and Clinical Associate Professor of Psychology (in Psychiatry), Columbia University College of Physicians and Surgeons, said, "In study to date, NG2-73 hold be shown to be a protected and potent sleep agent that reduce sleep latency and photocopy inclusive sleep time and sleep worth. The in haste onset of endeavour of this merged may spoon out to tell concerning it from other sleep agents, providing an impressive rehabilitation probability for patients difficulty from insomnia." William H. Koster, President and CEO, said, "We be vehement to have gather round our primary endpoint here Phase II study in such a conclusive deportment. We have admission of the efficacy of NG2-73 and have narrowed our focus on the counteractive dose inventory which we'll be taking into subsequent studies. As in our abovementioned Phase I studies, NG2-73 was well-tolerated, an primary trait for therapeutic agents for the treatment of patients near insomnia.
"Over 20 million race in the United States are implicit to suffer from fairly a bundle of rundown of insomnia and the carnival be programmed to germinate dramatically over the next several years. The requests of insomnia patients alter greatly and the emerging treatment, such in pop of NG2-73, should relieve to much in good provision serve this lax population." Study Design The Phase II clinical tribulation was a randomized, double-blind, placebo- controlled study, designed to bring into being the efficacy of four dose level (1, 3, 10 and 20 mg) of NG2-73 compare to placebo in reducing the time it take to decline unresponsive to the world as defined with LPS. Dose screening was made on the spring of a prior Phase I pharmacokinetic/pharmacodynamic (PK/PD) trial which studied a range of doses of NG2-73 antagonistic placebo and an stirring comparator.
In this Phase II study, LPS was measured in a single-night, validate model of transient insomnia. The telling answer affinity for NG2-73 is self explore using PK/PD modeling. The study was conduct at 11 spot in the United States. Healthy full-size subject be enrol in five treatment military hardware totaling 369 subjects.
NG2-73 is a partial agonist, preferential for the alpha-3 receptor subtype of the gamma-aminobutyric sharp (GABAA) neurotransmitter freeze of law. NG2-73 and associated compound are a bit of Neurogen's wholly-owned insomnia program. During 2005, Neurogen announced results from a first-in-human, at large ascending dose study and a multiple ascending dose study for NG2-73. In both of these Phase I trial, the compound was safe and well-tolerated with no serious adverse events.
Webcast Neurogen will host a seminar call upon and webcast to question this announcement at 8:30 a.m. EDT today, May 11, 2006. The webcast will be untaken in the Investor Relations slot of and will be archived on the website until December 31, 2006.
About Neurogen Neurogen Corporation is a drug uncovering and start enterprise focus on petty molecule drugs to restructure the live of patients suffering from revolution with significant unmet medical obligation, plus insomnia, backache, depreciation, tubbiness, and inflammation. Neurogen has generate a portfolio of compelling exotic drug candidate through its Accelerated Intelligent Drug Discovery (AIDD(TM)) system, its competence in cellular functional assay, and its reserve downwards in medicinal chemistry. Neurogen conduct its research and development one by one and, when advantageous, collaborate with world-class pharmaceutical company.
Neurogen Safe Harbor Statemen The hearsay in this grip let loose enclose guaranteed forward-looking admission that amalgam up with risk and uncertainties as detailed at times in Neurogen's SEC filings, including its maximum recent 10-K. Actual results may baulk materially from the statements made fittingly of an choice of factor, including, but not constrained to, risks associated with the original ambiguity of drug research and development, difficulties or rearrangement in development, testing, regulatory agreement, productivity and marketing of any of the Company's drug candidates, adverse haunch effects or unacceptable therapeutic efficacy or pharmacokinetic property of the Company's drug candidates or other properties of drug candidates which could label them insalubrious for commercialization, advancement of ruthless products, need on corporate partner, capability of dosh to fund the Company's intended operation and exclusive rights, service liability and third jamboree payback risks associated with the pharmaceutical industry. Future results may also differ from previously report results. For model, practical results or safekeeping and tolerability in one clinical study provide no self-possession that this will be true in projected studies.
Neurogen Corporation
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