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FDA Accepts NDA for Investigational Insomnia Drug Lemborexant

An FDA decision on the application is expected by December 27, 2019.

The US Food and Drug Administration (FDA) has accepted a New Drug Application (NDA) for lemborexant, an investigational treatment for insomnia, that was submitted in December 2018.

A Prescription Drug User Fee Act (PDUFA) date for an FDA decision has been set for December 27, 2019.

"Our ultimate goal for the development of a sleep-wake treatment is to bring to patients living with insomnia a new option that has the potential to improve their ability to fall asleep, stay asleep, and wake well the next morning," said Lynn Kramer, MD, Chief Clinical Officer and Chief Medical Officer, Neurology Business Group, Eisai. "This milestone for lemborexant brings us one step closer to addressing unmet needs for millions of patients who experience insomnia."

The NDA is supported by data from 2 pivotal phase 3 clinical trials of lemborexant, SUNRISE 1 and SUNRISE 2.

SUNRISE 1 evaluated lemborexant 5 mg and 10 mg versus a placebo and an active comparator— zolpidem tartrate extended release—in 1006 participants with insomnia disorder. Patients were all at least 55 years of age; 45% were 65 years or older.

The 1-month study met its primary outcome of change from baseline in mean latency to persistent sleep compared to placebo. Key secondary objectives of sleep efficiency and wake after sleep onset were also met.

SUNRISE 2 examined the safety and efficacy of lemborexant over the course of 12 months, with a placebo arm for the first 6 months. This study included a broader age range (18 to 88 years) in the 949 participants with insomnia disorder.

At the end of the 6-month period, significant reductions in patient-reported sleep onset latency were reported for lemborexant 5 mg (-21.81 minutes) and lemborexant 10 mg (-28.21 minutes) compared to placebo (-11.43 minutes). Additionally, the study met sleep efficiency and wake after sleep onset endpoints.

The most common reported adverse events for the lemborexant groups in SUNRISE 1 were headache and somnolence. In SUNRISE 2, the most common adverse events in the active treatment arms were somnolence, nasopharyngitis, headache, and influenza.

"Insomnia, a disorder of poor sleep quality, delayed onset, or insufficient quantity, causes impairment in functioning and has been correlated with long-term consequences for health and well-being," said John Renger, PhD, Vice President, Head of Research & Development and Regulatory Affairs, Imbrium Therapeutics. "We are dedicated to working with our partner Eisai to make this investigational treatment available to patients, pending regulatory approval."