Development and Regulatory status
Jan 19: NDA filed in US. Application is based on results of two pivotal PIII clinical studies in patients with insomnia, SUNRISE 1 (Study 304) and SUNRISE 2 (Study 303), enrolling approximately 2,000 patients, as well as important safety studies, including assessment of postural stability after middle-of-the-night awakening and a next-morning driving study .
Aug 15: Eisai and Purdue Pharma have formed a global development and commercialisation pact for Eisai´s experimental insomnia therapy lemborexant. The companies said they intend to share the cost of developing the drug which is entering PIII development for insomnia but may also be assessed in other indications under the alliance. If successful, lemborexant will be co-promoted in the US, and potentially other territories, with related costs and profits shared. In other countries, either company can potentially solely market the drug, paying the other a royalty. Also under the terms, Eisai will receive an undisclosed upfront payment from Purdue as well as certain other regulatory and commercial milestone payments .·
Trial or other data
Feb 19: PIII study NCT02952820 (SUNRISE 2) was a 12-month study of lemborexant in 949 adult patients (18 to 88 years of age, 28% aged over 65) with insomnia disorder, which was characterized by difficulty falling asleep and/or staying asleep. All patients received both active drug and placebo at some point in the study. Lemborexant (5 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, with median reductions of 21.81 minutes (5mg dose) and 28.2 minutes (10mg dose). Improvements in secondary endpoints sleep efficiency and subjective wake after sleep onset were also found .
Mar 18: Eisai & Purdue announce that the pivotal PIII study, SUNRISE 1, achieved its primary and key secondary objectives versus placebo and versus an active comparator (zolpidem tartrate extended release) in patients 55 years and older with difficulty staying asleep through the night. The study used objective PSG to determine if 5 mg and 10 mg lemborexant were superior to zolpidem ER 6.25 mg and to placebo. Lemborexant had rates of discontinuation due to adverse events (AEs) comparable to placebo, with the most common AEs in the lemborexant arms being headache and somnolence. Eisai and Purdue plan to present full results of SUNRISE 1 at an upcoming medical meeting in 2018 .
Jan 18: PIII SUNRISE-1 trial (NCT02783729) completes .
Nov 17: PIII trial (NCT02783729) is still recruiting pts; collection of primary outcome data due to complete Nov 17 .
Jun 16: Eisai initiated a PIII trial to evaluate the safety and efficacy of lemborexant in patients with insomnia (NCT02783729; E2006G000-304). In the randomised, double-blind study, enrolment of approximately 950 patients, aged 55 years and older, is underway in the US, France, Germany, Italy, Spain, Japan and the UK, and is expected to extend to Canada .·