Inpharma 1590 - 2 Jun 2007

NG 273 may put sleepless nights torest

NG 273,* a partial GABAA receptor agonist, ispromising for the treatment of insomnia, according totwo studies presented at the annual meeting of theAmerican Psychiatric Association.

In a crossover phase I study, data were evaluated for19 subjects who received single oral doses of NG 2731mg, 3mg, 5mg and 10mg, zolpidem 10mg, andplacebo. The plasma concentrations associated withhalf-maximal visual analog scale effects wereapproximately 13-fold greater for zolpidem than forNG 273. Moreover, the Cmax associated with NG 273was approximately 6-fold less than that associated withzolpidem. Overall, exposure-response modellingdemonstrated that a dose of NG 273 4–5mg wouldprovide a maximal response comparable to that ofzolpidem 10mg.

In a multicentre phase IIa study, data were evaluatedfor 369 healthy subjects who were randomised toreceive NG 273 1mg, 3mg, 10mg or 20mg, or placebo,2.5 hours prior to bedtime. Latency to Persistent Sleep(LPS) was significantly reduced for NG 273 recipients,compared with placebo recipients. The mean LPS timesfor NG 273 1mg, 3mg, 10mg and 20mg, and placebo,were 17.8, 10.6, 7.8, 6.6, and 30.8 minutes,respectively. Moreover, at doses of ≥ 3mg, NG 273demonstrated a significant effect on Total Sleep Timeand Sleep Efficiency, compared with placebo.* Neurogen Corporation; phase II in the US for insomnia

Neurogen Corporation. Neurogen Proprietary Insomnia Compound Data Presentedat American Psychiatric Association Annual Meeting. Media Release : 23 May2007. Available from: URL: http://www.neurogen.com 809076095

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Inpharma 2 Jun 2007 No. 15901173-8324/10/1590-0001/$14.95 Adis © 2010 Springer International Publishing AG. All rights reserved