This Phase III, multi-center, placebo-controlled, four-week trial evaluated 322 patients with chronic primary insomnia. Patients were randomized to receive either 20mg or 50mg of tasimelteon or placebo over the course of four weeks.
The primary endpoint consisted of the evaluation of the immediate and short-term (average of nights one and eight) ability of tasimelteon to improve sleep onset as measured by latency to persistent sleep (LPS) through polysomnography.
Secondary endpoints evaluated tasimelteon’s ability to maintain improvements on sleep onset after long-term (average of nights 22 and 29) use of the compound as well as measures of sleep duration (total sleep time, TST) and sleep maintenance (wake after sleep onset, WASO). Patients were eligible for the study if symptoms of insomnia were chronic and LPS was greater than 30 minutes.
These results demonstrate that tasimelteon was able to improve LPS significantly, and that this effect persisted for the four week duration of the study.
Paolo Baroldi, chief medical officer of Vanda, said: “We are excited that the results of this Phase III chronic insomnia study demonstrate the clinical utility of tasimelteon and the ability of the compound to treat sleep disorders over a period of four weeks.”