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 , 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 deter.