Jazz Pharmaceuticals Announces FDA Approval of Sunosi (solriamfetol) for Excessive Daytime Sleepiness in Narcolepsy and Obstructive Sleep Apnea

VCBeat (WeChat Official Account: vcbeat) learned from foreign media that on March 20, U.S. local time, Jazz Pharmaceuticals, a biopharmaceutical company headquartered in California, announced that its newly developed drug, Sunosi (solriamfetol), had passed the review of the U.S. Food and Drug Administration (FDA) and was approved for improving and treating sleep disorders such as narcolepsy or obstructive sleep apnea (OSA).

Jazz Pharmaceuticals is a global biopharmaceutical company primarily focused on two therapeutic areas: sleep disorders and hematologic malignancies. The company has one marketed product in the sleep disorder segment and four marketed products in the hematologic malignancy segment. The name “Jazz” was chosen because, in the eyes of its founders, biomedical research and development resembles jazz composition, requiring improvisation and continuous refinement. Furthermore, the unique structural nature of jazz scores and their appeal to individual listeners parallel the characteristics of pharmaceutical products. Founded in 2003, Jazz Pharmaceuticals went public on the NASDAQ stock exchange (NASDAQ: JAZZ) on May 31, 2007.

Sunosi is the first FDA-approved dual-acting dopamine and norepinephrine reuptake inhibitor (DNRI) that can help patients with narcolepsy, obstructive sleep apnea (OSA), or excessive daytime sleepiness improve their wakefulness. According to officially published data, the approved daily dosage of Sunosi for treating narcolepsy is 75 mg or 150 mg, and for treating OSA, it is 37.5 mg, 75 mg, or 150 mg.

During the 12-week clinical trials, patients taking either 75 mg or 150 mg doses of Sunosi experienced significant improvements in sleep quality and maintained daytime wakefulness. The FDA approved the drug after analyzing data from Jazz Pharmaceuticals’ clinical trials, which demonstrated that Sunosi was significantly more effective than placebo in alleviating symptoms of obstructive sleep apnea (OSA) and narcolepsy.

The most common adverse reactions observed in the treatment of OSA and narcolepsy include headache, nausea, decreased appetite, and anxiety, with an incidence rate greater than 5% and significantly higher than that associated with placebo. Jazz Pharmaceuticals administered Sunosi to 900 adult patients with narcolepsy or OSA and conducted a six-month observational assessment, finding that the incidence of adverse reactions was consistent with that of placebo.

Currently, the mechanism of action of Sunosi remains unclear, but it is generally believed to act through DNRI activity.

“Excessive daytime sleepiness can severely impact patients’ normal daily lives and work. With this approval, we are able to offer patients a novel daytime medication that helps maintain wakefulness throughout the day,” said Bruce Cozadd, Chief Executive Officer of Jazz Pharmaceuticals. “This FDA approval marks an important milestone for Jazz Pharmaceuticals, and we will continue to provide new treatment options for patients suffering from frequent neurasthenia and sleep disorders.”

According to the final decision of the U.S. Drug Enforcement Administration (DEA), Sunosi is expected to be launched in the United States within 90 days after FDA approval.

(Compiled by: Wang Chan)