ARENA PHARMA BEGINS TRIAL OF INSOMNIA TREATMENT

Arena Pharmaceuticals announced that it initiated dosing in a Phase II clinical trial of APD125 in chronic insomnia patients. APD125 is an orally available drug candidate discovered by Arena with the potential to reduce insomnia symptoms and improve sleep maintenance and quality.

The Phase II trial of APD125 is a randomized, double-blinded, placebo-controlled study evaluating the safety and efficacy of nighttime dosing in patients with chronic insomnia. This trial will evaluate standard measurements of sleep, such as wake after sleep onset, number of awakenings, total sleep time and latency to persistent sleep, and will enroll a total of approximately 100 male and female patients in 25 clinical sites in the U.S. This trial employs a crossover design, meaning that every patient receives both active doses of APD125 (10 and 40 mg) and placebo in random order, for one week, separated by at least one week to allow for wash out of the study drug.

By selectively targeting the 5-HT2A receptor, APD125 acts through a different mechanism than currently marketed insomnia drugs and inhibits one of several central nervous system activating pathways, according to the company. Because of the different mechanism of action, APD125 may not have the side effects or abuse potential generally associated with currently marketed GABA-A drugs, the company said.