Arena Pharmaceuticals Inc, San Diego, Calif, has initiated screening for the Phase 2b clinical trial for the oral drug candidate APD125, for the treatment of insomnia. It is hoped that the drug candidate will prove to reduce insomnia symptoms and improve sleep maintenance and quality.
The Phase 2b study is a subjective study to evaluate the effectiveness and tolerability of APD125 in patients with primary insomnia. The study will be placebo controlled and will include nearly 675 male and female patients in 70 clinical sites across the United States. It will evaluate the placebo and two doses (20mg and 40mg) of APD125 over 14 nights of treatment.
During the Phase 2a study, the drug led to statistically sizeable improvements in objective measurements of sleep maintenance without any limiting next day cognitive effects.
“We are very encouraged by the emerging profile of APD125. We believe APD125 has the potential to significantly improve sleep maintenance and quality for patients with insomnia without the potential for dependence of impairing psychomotor function,” says Jack Lief, president and CEO of Arena.