Eisai Inc. gains U.S. FDA approval for DAYVIGO (lamborexant) based on the Robust Clinical Development Program which included two clinical trials of nearly 2000 patients suffering from insomnia. Eisai Inc. is the pharmaceutical subsidiary of Eisai Co., Ltd. has announced the DAYVIGO’s approval by the U.S. Food and Drug Administration for the treatment of adult insomnia patients, characterized by irregular sleep, sleeping difficulties and difficulties in sleep maintenance.
The clinical study evaluated DAYVIDO versus placebo for more than a month and DAYVIGO versus placebo for the whole six months. DAYVIGO can be classified as a controlled substance as recommended by the FDA and this recommendation is forwarded to the U.S. Drug Enforcement Administration (DEA). It will be commercially available as scheduled by the DEA, expected within 90 days.
One of the principal investigators in the clinical studies and the former chairman of the Board of the National Sleep Foundation, Russell Rosenberg said that insomnia is a chronic disorder having different negative effects and long-term health consequences. The outcomes of these trials have given evidence on the efficacy of DAYVIGO. The results showed that it may show improvement in the sleep-maintenance of patients.
Lemborexant is an orexin receptor antagonist, inhibits signaling of orexin by competitive binding to both receptors; orexin receptor 1 and orexin receptor 2. Orexin signaling promotes wakefulness periods. In individuals with sleeping disorders, the receptors are not functioning normally.
The approval was based on the results of the clinical development program which includes two pivotal Phase 3 study – Study 1 which was randomized six months, double-blind, multicentre placebo-controlled trial in adult patients with age 18 or older who met DSM-5 criteria of insomnia condition. Study 2 which was randomized one month, double-blind, multicenter placebo-controlled trial in an adult female age 55 and older and male with age of 65 and older met DSM-5 criteria.
In one-month and twelve-month controlled efficacy and safety trials, DAYVIGO was not linked with rebound insomnia following discontinuation of the treatment. Tyrer Benzodiazepine Withdrawal Symptom Questionnaire assessed the withdrawal effects following the treatment discontinuation in patients who had received DAYVIGO 10mg or 5mg. The outcomes provided no withdrawal effects evidence following discontinuation.
In addition to the pivotal trials, Eisai also conducted various studies for further evaluation of the safety of the DAYVIGO which includes driving study and study which assessed its effects on memory performance and postural stability.
Chief Clinical Officer, Neurology Business Group, Eisai, Lynn Kramer, MD. said that FDA approval is exciting because it is the first approved treatment to report safety outcomes, shows safe profile and efficacy data on sleep maintenance. They are looking forward to making this new treatment available to the patients suffering from insomnia disorder.
Some warning and precautions were listed including:
- Central Nervous System (CNS) Depressant Effects and Daytime Impairment.
- Sleep Paralysis, Hypnagogic/Hypnopompic Hallucinations, and Cataplexy-Like Symptoms.
- Complex Sleep Behaviors.
- Worsening of Depression/Suicidal Ideation
- Patients with Compromised Respiratory Function
- Need to Evaluate for Co-Morbid Diagnoses and some other adverse effects.