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Neurogen Proprietary Insomnia Compound Data for Two Studies,Presented at Associated Professional Sleep Societies Annual Meeting

eep had been significantly more refreshing than did the placebo group. At 1, 3, and 10mg, subjects felt alert and more than 87% of subjects considered their ability to concentrate as "very good" or "excellent" the morning following dosing, which was similar to the placebo group.

In this study, NG2-73 was generally well tolerated with adverse events (e.g. somnolence) attributable to the pharmacological action of the drug. There were no deaths, or drug-related serious adverse events or discontinuations, and no clinically important changes in safety laboratory reports, vital signs or electrocardiograms (ECGs).

In this study, NG2-73 was shown to be a potent sedative hypnotic which significantly reduced LPS at all doses tested, which was supported by subjective responses indicating rapid sSL. Most subjects expressed good concentration, alertness, and feeling refreshed the next morning. In this study, NG2-73 was also generally well-tolerated.

"Pharmacokinetic-Pharmacodynamic Effects of NG2-73, a Novel GABA(A) Agonist, and Zolpidem" (Phase 1)

NG2-73 is a GABA(A) receptor partial agonist which has preference for the alpha-3 subunit. In vivo animal experiments suggest that NG2-73 will have an improved side effect profile compared to zolpidem based on ethanol interaction and on assessments of learning and memory at equipotent hypnotic doses. The objectives of this study were to evaluate the relationship of dose, plasma concentration, and time to the pharmacokinetics (PK) and pharmacodynamics (PD) of NG2-73 at doses of 1, 3, 5, and 10 mg and zolpidem 10 mg versus placebo in healthy subjects.

This was a single-center, randomized, double-blind, placebo-controlled, six-way crossover study of single oral doses of NG2-73 administered to 19 healthy volunteers. Safety and tolerability were assessed, and kinetic-dynamic relationships were determined using plasma concentrations and multiple measures of PD including a visual analog scale of sedation (V
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