Arena initiates Phase IIb insomnia trial

The study will evaluate the efficacy and tolerability of APD125 in patients with primary insomnia characterized by difficulty maintaining sleep. The trial, which is expected to enroll a total of approximately 675 male and female patients in about 70 clinical sites in the US, will evaluate two doses (20mg and 40mg) and placebo over 14 nights of treatment. The trial will evaluate standard subjective measurements of sleep, including change from baseline in subjective number of awakenings after sleep onset, which is the primary endpoint.

Jack Lief, Arena’s president and CEO, said: “We believe APD125 has the potential to significantly improve sleep maintenance and quality for patients with insomnia without the potential for dependence or impairing psychomotor function.”