![Eisai and Purdue Pharma Present Efficacy and Safety Data from Second Pivotal Phase 3 Study at the Sleep Research Society?s Conference: Advances in Sleep and Circadian Science](https://pharmashots.com/public/default-image/Press-Release-768x411.png )
Eisai and Purdue Pharma Present Efficacy and Safety Data from Second Pivotal Phase 3 Study at the Sleep Research Society?s Conference: Advances in Sleep and Circadian Science
![](https://pharmashots.com/wp-content/uploads/2019/02/PR-e1550232094431.png)
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).
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. The most common AEs reported, greater than 5 percent in either lemborexant treatment arm and greater than placebo, were somnolence, headache, and influenza. Discontinuation rates due to AEs were comparable between placebo and lemborexant 5 mg (3.8 percent and 4.1 percent, respectively), and higher for lemborexant 10 mg (8.3 percent).
?These findings add to the growing body of clinical data supporting the development of lemborexant for the treatment of insomnia, and we look forward to presenting 12-month results from the study in a future scientific forum,? said Lynn Kramer, MD, Chief Clinical Officer and Chief Medical Officer, Neurology Business Group, Eisai. ?It remains our aspiration to bring a medicine to physicians and patients that helps patients sleep well at night and wake well in the morning.?
SUNRISE 2 is one of two Phase 3 safety and efficacy studies of lemborexant conducted by Eisai and Purdue Pharma.?These studies supported the New Drug Application for lemborexant for the treatment of insomnia, filed with the U.S. Food and Drug Administration, on December 27, 2018. In Japan, an application is scheduled to be filed within fiscal 2018.
?The six-month findings from SUNRISE 2 are exciting, highlighting improvements in subjective measures of both sleep onset and sleep maintenance,? said John Renger, PhD, Head of Research & Development and Regulatory Affairs, Purdue Pharma. ?SUNRISE 2 was a robust Phase 3 clinical study in which the self-reported patient outcomes are encouraging as they reflect the patients? perception of lemborexant?s impact on enabling the patient to both fall asleep faster and stay asleep longer.?
Lemborexant, which acts on the orexin neurotransmitter system and is believed to regulate sleep and wake by dampening wakefulness without impeding the ability to awaken to external stimuli, is being jointly developed by Eisai and Purdue Pharma for the treatment of multiple sleep-wake disorders, including insomnia disorder. In addition to the treatment of insomnia disorder, a Phase 2 clinical study of lemborexant in patients with irregular sleep-wake rhythm disorder and mild to moderate Alzheimer's dementia is underway. Information about ongoing clinical studies is available at clinicaltrials.gov.
Eisai and Purdue Pharma are striving to address new unmet medical needs and to improve the lives of patients and their families.
This release discusses investigational uses of an agent in development and is not intended to convey conclusions about efficacy or safety. There is no guarantee that such an investigational agent will successfully complete clinical development or gain health authority approval.
Contacts:
-
Eisai Co., Ltd.
Public Relations Department +81-(0)3-3817-5120
-
Purdue Pharma L.P.
Danielle Lewis +1-203-588-7653
- 1. About Lemborexant
- 2. About SUNRISE 21
- 3. About Sleep Disorders
- 4.?About Eisai Co., Ltd
- 5. About Purdue Pharma L.P.
![(New Window)](https://www.eisai.com/common/images/icon_blank.png)