US court upholds Avadel's narcolepsy drug amid exclusivity dispute

The US District Court for the District of Columbia has upheld a decision by the US Food and Drug Administration (FDA) that allows Avadel Pharmaceutical’s narcolepsy drug, Lumryz (sodium oxybate), to remain on the market. This ruling rejects Jazz Pharmaceuticals' bid to overturn the FDA's approval. Jazz argued that the FDA’s approval of Lumryz infringed on the market exclusivity granted to its own narcolepsy treatment, Xywav (sodium oxybate), under the Orphan Drug Act (ODA) in 2020. This exclusivity typically prevents the approval of similar drugs for the same condition for a set period.

In May 2023, despite this exclusivity, the FDA approved Lumryz, which contains the same active ingredient as Xywav but has a different dosage regimen. Xywav requires a split-dose schedule, necessitating patients to wake up for a second dose during the night. Lumryz, on the other hand, is taken as a single nightly dose, which the FDA considered to be “clinically superior” due to the convenience it offers to patients.

Following the FDA’s approval of Lumryz, Jazz filed a lawsuit claiming that Lumryz and Xywav are essentially the same drug and that the approval of Lumryz violated Xywav’s exclusivity period. Jazz also argued that the FDA deviated from its established policy by not requiring Lumryz to demonstrate safety comparable to Xywav. Jazz pointed out that Lumryz’s higher sodium content could pose additional health risks for narcolepsy patients.

The court ruled in favor of the FDA and Avadel on all counts. The ruling affirmed that the FDA acted within its authority when it determined that Lumryz’s single-dose regimen qualified as “clinical superiority,” distinguishing it from Xywav under the FDA’s criteria. The court also dismissed Jazz’s claims regarding safety, noting that there is no policy mandating new orphan drugs must match the safety profiles of existing treatments.

This decision permits Avadel to market Lumryz with its own seven-year exclusivity, presenting direct competition to Jazz’s Xywav in the narcolepsy treatment market. According to projections by GlobalData’s Pharma Intelligence Center, Xywav is expected to generate $1.85 billion in sales by 2030, while Lumryz is forecasted to bring in $639 million in the same year.

In a statement accompanying the court ruling, Avadel CEO Greg Divis expressed satisfaction with the court’s decision. He highlighted that the ruling supports the FDA’s determination of Lumryz's clinical superiority and confirms final approval for its use in adults with narcolepsy. Divis emphasized that with this decision, Lumryz will continue to be available to the narcolepsy community and maintain its orphan drug exclusivity.

Additionally, Lumryz has gained pediatric approval from the FDA for treating children aged seven and older with narcolepsy as of October 2024. The drug is approved for managing cataplexy or excessive daytime sleepiness (EDS) in narcolepsy patients. Lumryz carries a boxed warning due to its nature as a central nervous system depressant and its potential for abuse and misuse.

Narcolepsy is a chronic neurological disorder that disrupts the brain’s ability to regulate sleep-wake cycles, making it difficult for individuals to control when they wake or sleep.