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Arena Pharmaceuticals Presented Positive Phase 2a Clinical Trial Results of APD125 for the Treatment of Insomnia at 22nd Annual Meeting of the Associated Professional Sleep Societies
Date:6/12/2008

with primary insomnia. The trial evaluated standard PSG measurements of sleep, such as WASO, WTDS, number of awakenings, number of arousals, total sleep time and latency to persistent sleep, and enrolled a total of 173 male and female patients, ages 18-64, in 24 sleep research centers in the United States. To qualify for enrollment, patients were required to have paired screening PSGs that demonstrated an average WASO greater than or equal to 60 minutes, with neither PSG less than 45 minutes.

Every patient received both active doses of APD125 (10 mg and 40 mg) and placebo in random order for one week, separated by a seven to nine day washout period between each dosing period. Efficacy was measured objectively by averaging PSG values for N 1/2 and for N 6/7, versus baseline values obtained by averaging results from the screening PSGs.

About APD125

Discovered by Arena, APD125 is a novel and oral selective inverse agonist of the 5-HT2A serotonin receptor. The vast majority of approved drugs for insomnia work by activating the GABA-A receptor complex in the brain, causing a general suppressive effect on the central nervous system, or CNS. These GABAergic drugs are generally associated with CNS side effects, including a sensation of dullness and lethargy upon awakening, often referred to as the "hangover effect." Other potential problems associated with the GABAergic drugs include the risk of developing tolerance and drug dependency in at-risk populations. In addition, GABAergic drugs are scheduled controlled substances by the Drug Enforcement Administration due to their potential for abuse.

APD125 acts through a different mechanism than currently marketed insomnia drugs. Arena believes that by selectively targeting the 5-HT2A receptor, APD125 blocks one of several CNS activating pathways rather than initiating a general CNS suppressive effect. Because of the different mechanism of action, APD125 may not have the side effects or abuse potenti
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SOURCE Arena Pharmaceuticals, Inc.
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