Phase III SUNRISE study of E 2006 shows improvement in insomnia.- Eisai + Purdue Pharma

Eisai and Purdue Pharma announced six-month results from SUNRISE 2, a long-term Phase III clinical study evaluating the efficacy and safety of E 2006 (lemborexant), for the treatment of insomnia, a sleep-wake disorder. At the end of the six-month, placebo-controlled treatment period, treatment with lemborexant at either 5 mg or 10 mg resulted in statistically significant improvements compared to placebo in patient-reported (subjective) sleep onset latency (sSOL), the study's primary efficacy endpoint, and subjective sleep efficiency (sSE) and subjective wake after sleep onset (sWASO), the study's key secondary endpoints.

Six-month results from the study showed that median reductions from baseline in sSOL with lemborexant 5 mg (-21.81 minutes) and 10 mg (-28.21 minutes) were larger and statistically significant compared to placebo (-11.43 minutes) at the end of month six (p<0.0001 for all treatment groups). in addition, improvements from baseline, as measured by least squares mean (lsm), in sse with lemborexant 5 mg (14.19 percent, p="0.0001)" and 10 mg (14.31 percent, p><0.0001) were larger and statistically significant compared to placebo (9.64 percent) at the end of month six. reductions from baseline in swaso, as measured by lsm, with lemborexant 5 mg (-46.75 minutes, p="0.0005)" and 10 mg (-41.95 minutes, p="0.0105)" were larger and statistically significant compared with placebo (-29.28 minutes) at the end of month six.>

Most adverse events (AEs) reported were mild to moderate. Serious AEs were reported at a rate of 2.2 percent (lemborexant 5 mg), and 2.9 percent (lemborexant 10 mg), and 1.6 percent (placebo); only one was considered treatment-related. Data were presented at the Sleep Research Society's Advances in Sleep and Circadian Science conference.