US court confirms Avadel's approval for narcolepsy drug in dispute over exclusive rights

The drugs from Avadel and Jazz Pharmaceutical treat narcolepsy, a chronic neurological disorder that affects the brain's ability to control sleep-wake cycles. Photo credit: Sorapop Udomsri via Shutterstock.

The U.S. District Court for the District of Columbia has upheld the U.S. Food and Drug Administration's (FDA) decision to keep Avadel Pharmaceutical's narcolepsy drug Lumryz (sodium oxybate) on the market, upholding Jazz Pharmaceuticals' attempt to challenge the FDA -Approval revoked, rejected.

Jazz argued that the approval violated the seven-year market exclusivity granted to its narcolepsy drug Xywav (sodium oxybate) in 2020 under the Orphan Drug Act (ODA), a similar orphan drug for the same condition.

However, in May 2023, the FDA approved Avadel's Lumryz, which contains the same active ingredient but differs in dosage. Unlike Xywav's split-dose schedule, which requires users to wake up for a second dose, Lumryz is taken as a single nighttime dose, which the FDA deemed “clinically superior” due to the added convenience for patients.

In response, Jazz filed a lawsuit alleging that Lumryz and Xywav were essentially “the same drug” and that Lumryz's approval violated Xywav's exclusivity period.

Jazz also claimed the FDA deviated from “long-standing policy” by not requiring Lumryz to demonstrate “comparable safety” to Increase health risks for narcolepsy patients.

The court ruled in favor of the FDA and Axadel on all points. It concluded that the FDA acted within its authority when it determined that Lumryz's single-dose regimen represented “clinical superiority” and was different from Xywav as defined by the FDA. The court also dismissed Jazz's “comparable safety” claim, finding that there was no established policy requiring new orphan drugs to match the safety profile of previous drugs.

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Ultimately, the court found that the FDA's clinical superiority assessment was appropriate and met regulatory standards.

This decision allows Axadel to market Lumryz with its seven-year exclusivity, providing direct competition to Jazz's Xywav in the narcolepsy treatment market. According to GlobalData's Pharma Intelligence Center, Xywav is expected to generate $1.85 billion in sales in 2030, while Lumryz is expected to generate $639 million in the same year.

GlobalData is the parent company of Pharmaceutical technology.

In Avadel's announcement accompanying the court ruling, Greg Divis, CEO of Avadel, said: “We are pleased with the court's decision in favor of the FDA's determination of clinical superiority of Lumryz in conjunction with its final approval for use in adults with narcolepsy. “With the court’s decision, Lumryz remains available to the narcolepsy community and retains its orphan drug exclusivity.”

Lumryz received FDA pediatric approval in October 2024 for people age seven and older with narcolepsy. The drug is approved for the treatment of cataplexy, or excessive daytime sleepiness (EDS), in narcolepsy patients. There is a warning label for Lumryz as a central nervous system depressant and because of its potential for misuse and misuse.

Narcolepsy is a chronic neurological disorder that affects the brain's ability to regulate sleep and wake cycles, meaning people cannot decide when to wake up or sleep.