Home Fairfield New insomnia drug from Purdue Pharma submitted to FDA

New insomnia drug from Purdue Pharma submitted to FDA

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Purdue Pharma LP and Japan’s Eisai Co. Ltd. have submitted a new drug application to the U.S. Food and Drug Administration (FDA) for lemborexant as a treatment for insomnia.

According to the companies, lemborexant acts on the orexin neurotransmitter system and is designed to regulate the sleep-wake cycle by dampening wakefulness without impeding the ability to awaken to external stimuli. Stamford-headquartered Purdue Pharma and Tokyo-based Eisai submitted their application was based on the results of two Phase 3 clinical studies involving approximately 2,000 patients with insomnia.

The companies are also conducting a Phase 2 clinical study of lemborexant in patients with irregular sleep-wake rhythm disorder and mild to moderate Alzheimer’s dementia.

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