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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

ments in sleep maintenance, including wake after sleep onset (WASO) and wake time during sleep (WTDS). WASO, the primary endpoint, decreased from baseline by 52.5 minutes (10 mg) and 53.5 minutes (40 mg) at nights one and two (N 1/2) (p<0.0001 for both vs. placebo) and by 51.7 minutes (p=0.01) and 48.0 minutes (p=0.2) at nights six and seven (N 6/7), respectively. WTDS decreased from baseline by 45.8 minutes (10 mg) and 46.6 minutes (40 mg) at N 1/2 (p<0.0001 for both vs. placebo) and by 46.1 minutes (10 mg) and 46.9 minutes (40 mg) at N 6/7 (p<0.001 for both vs. placebo).

Importantly, the number of awakenings and number of arousals improved significantly for both doses and time points (p<0.0001 at both N 1/2 and N 6/7 at 10 mg and 40 mg for both variables). Changes in the number of awakenings were 0.0, -2.5 and -3.1 at N 1/2 and -0.9, -2.3 and -2.5 at N 6/7 for placebo, 10 mg and 40 mg, respectively. Changes in the number of arousals were +3.8, -5.8 and -8.1 at N 1/2 and +2.5, -4.8 and -6.7 at N 6/7 for placebo, 10 mg and 40 mg, respectively. The beneficial effect of APD125 was also evidenced by a significant reduction in wake time during the middle of the night (hours three through six). APD125 also significantly increased the time spent in deep (Stage 3 and 4) sleep while decreasing the amount of time spent in the lighter stages of sleep (Stages 1 and 2), providing further evidence for the sleep maintenance properties of APD125. Time in REM sleep was not meaningfully affected.

Treatment with APD125 was well tolerated, with no reports of serious adverse events and no emerging safety findings as compared to placebo. No next day impairment of cognition or coordination was observed and there was no evidence of treatment withdrawal symptoms.

APD125 Phase 2a Study Design

The Phase 2a trial of APD125 was a randomized, double-blind, placebo-controlled, three-way crossover study evaluating the safety and efficacy of nighttime dosing in patients
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SOURCE Arena Pharmaceuticals, Inc.
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