The US District Court for the District of Columbia has upheld the decision by the US Food and Drug Administration (FDA) to keep Avadel Pharmaceutical’s narcolepsy drug, Lumryz (sodium oxybate) on the market, rejecting Jazz Pharmaceuticals’ attempt to overturn the FDA approval.
Jazz argued that the approval infringed on the seven-year market exclusivity granted to its narcolepsy drug, Xywav (sodium oxybate), under the Orphan Drug Act (ODA) in 2020. The FDA had granted Xywav exclusivity, which typically prevents the approval of any 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 its dosing regimen. Unlike Xywav’s split-dose schedule – requiring users to wake up for a second dose – Lumryz is taken as a single nightly dose, which the FDA deemed as “clinically superior” due to its added convenience for patients.
In response, Jazz filed a lawsuit, contending that Lumryz and Xywav are essentially the “same drug” and that the approval of Lumryz infringed upon Xywav’s exclusivity period.
Jazz also claimed the FDA deviated from “longstanding policy” by not requiring Lumryz to demonstrate “comparable safety” to Xywav, noting that Lumryz’s formulation has higher sodium content, potentially raising health risks for narcolepsy patients.
The court ruled in favour of the FDA and Axadel on all counts. It concluded that the FDA acted within its authority in determining that Lumryz’s single-dose regimen constituted “clinical superiority”, making it distinct from Xywav under the FDA’s definition. The court also dismissed Jazz’s claim regarding “comparable safety”, noting there is no established policy requiring new orphan drugs to match the safety profile of previous drugs.
Ultimately, the court found the FDA’s clinical superiority assessment reasonable and consistent with regulatory standards.
This decision allows Axadel to market Lumryz with its seven-year exclusivity, posing direct competition to Jazz’s Xywav in the narcolepsy treatment market. Xywav is set to pull in $1.85bn in sales in 2030 while Lumryz is forecast to generate $639m in the same year, as per GlobalData’s Pharma Intelligence Center.
GlobalData is the parent company of Pharmaceutical Technology.
In Avadel’s announcement accompanying the court ruling, its CEO Greg Divis said: “We are pleased with the court’s ruling in favour of the FDA’s clinical superiority determination for Lumryz in conjunction with final approval for use in adults with narcolepsy. With the court’s decision, Lumryz will remain available to the narcolepsy community and retain its orphan drug exclusivity.”
Lumryz secured paediatric approval from the FDA for those seven years and older with narcolepsy in October 2024. The drug is approved for the treatment of cataplexy or excessive daytime sleepiness (EDS) in narcolepsy patients. Lumryz has a boxed warning as a central nervous system depressant, and for its potential for abuse and misuse.
Narcolepsy is a chronic neurological disorder that impacts the brain’s ability to regulate sleep and wake cycles, meaning people cannot choose when to wake or sleep.
