Eisai Launches Novel Dual Orexin Receptor Antagonist DAYVIGO® (Lemborexant) in Japan for the Treatment of Insomnia

TOKYO, July 13, 2020 /PRNewswire/ -- Eisai Co., Ltd. (Headquarters: Tokyo, CEO: Haruo Naito, “Eisai”) recently announced that it launched in Japan on July 6, 2020, DAYVIGO, an orexin receptor antagonist developed in-house.^®2.5 mg, 5 mg, and 10 mg tablets (lemborexant) for the treatment of insomnia. Eisai received marketing and manufacturing approval for this pharmaceutical product on January 23, 2020, and it was added to the National Health Insurance Drug Price List in Japan on April 22, 2020.

DAYVIGO^®is a dual orexin receptor antagonist that inhibits orexin neurotransmission and regulates the sleep-wake rhythm by competitively binding to two orexin receptor subtypes (OX1R and OX2R). DAYVIGO^®Acts on the orexin neurotransmitter system and is believed to promote sleep onset, sleep maintenance, and wakefulness by regulating the sleep-wake rhythm.

DAYVIGO^®Approval in Japan was based on two pivotal Phase III trials conducted in adult patients with insomnia^1，2(SUNRISE 1 and SUNRISE 2) clinical study results and 106³and Study 108⁴Evaluation Results of Residual Effects, Including Midnight Awakenings, Next-Morning Postural Stability (a Predictor of Falls), and Memory

SUNRISE 1 Conducted in North America and Europe¹Clinical trials, through objective assessment using overnight polysomnography, confirmed that DAYVIGO, compared with zolpidem tartrate extended-release formulation (6.25 mg, not yet approved in Japan) and placebo^®Significantly shorten or improve sleep onset latency (primary endpoint), as well as increase sleep efficiency and improve wake after sleep onset (secondary endpoints). Conducted globally, including in Japan, SUNRISE 2²In clinical trials, subjective assessments of patients using sleep diaries confirmed that, compared with placebo, DAYVIGO significantly shortened sleep onset latency (primary endpoint) and improved subjective sleep efficiency and subjective wakefulness after sleep onset (secondary endpoints). These effects were observed in two trials.^®The main side effects are somnolence, headache, dizziness, and fatigue. Both study analyses indicated that DAYVIGO^®It does not cause rebound insomnia, nor is there evidence of withdrawal effects upon discontinuation; furthermore, it has been demonstrated that patients taking the medication for up to one year do not develop physical dependence.

In a dedicated safety study (Study 106)³in, although the 5 mg and 10 mg doses of DAYVIGO^®Did not cause statistically significant impairment in driving performance the following morning in adult or elderly subjects (compared with placebo), but some individuals taking 10 mg DAYVIGO^®subjects’ driving ability was impaired. Another dedicated safety study (Study 108)⁴Midnight safety and its effects on next-morning motor stability and memory were evaluated. DAYVIGO was assessed in two randomized, placebo- and active-controlled trials.^®Effects on Next-Day Driving Stability and Memory. Two Doses of DAYVIGO^®(5 or 10 mg) showed no significant differences compared with placebo in next-day motor stability or memory. Although patients should be advised of the potential for midnight motor instability and impaired attention and memory, DAYVIGO^®No worsening of safety signals was observed between the group and the placebo group.

In June 2020, DAYVIGO was launched in the United States.^®, for the treatment of adult patients with insomnia, characterized specifically by difficulties with sleep onset and/or sleep maintenance. In addition, Eisai submitted DAYVIGO in Canada and Australia^®New Drug Application.

Insomnia is characterized by difficulty initiating sleep, difficulty maintaining sleep, or both, despite adequate opportunity for sleep, which may impair daytime functioning, such as causing fatigue, difficulty concentrating, and irritability.^5，6Insomnia is one of the most common sleep-wake disorders, with a high prevalence. Approximately 30% of adults worldwide experience symptoms of insomnia.^7，8The prevalence is particularly higher among the elderly, many of whom suffer from insomnia symptoms that persist for months or even years. Consequently, insomnia leads to various societal losses, such as prolonged absenteeism and reduced productivity. It also increases the risk of falls in the elderly.⁹

With DAYVIGO^®of its launch, Eisai will continue to prioritize the provision of appropriate usage and safety information. By providing DAYVIGO^®As a new option for treating insomnia, Eisai aims to improve the quality of active daytime life for patients with insomnia by promoting rapid sleep onset and high-quality sleep, thereby contributing to the restoration of daytime function and recovery.