BRIEF—Avadel sues FDA and HHS over Lumryz NDA

Avadel CNS Pharmaceuticals, a subsidiary of Avadel Pharmaceuticals, has filed an Administrative Procedure Act suit against the US Food and Drug Administration (FDA), the US Department of Health and Human Services, the Secretary of Health and Human Services and the Commissioner of Food and Drugs in the US District Court for the District of Columbia related to the New Drug Application (NDA) for Lumryz (sodium oxybate; formerly known as FT218), the company revealed in a filing with the Securities and Exchange Commission.

This suit alleges that FDA’s decision requiring Avadel CNS to file a patent certification concerning US Patent No 8,731,963 was arbitrary, capricious and contrary to law and asks the Court to vacate the FDA’s decision and order FDA to take final action on the Lumryz NDA.

Avadel is development Lumryz for the treatment of excessive daytime sleepiness (EDS) or cataplexy in adults with narcolepsy.

The suit is based on whether the drug would infringe on one of the patents that protect Jazz Pharmaceuticals’ treatment for narcolepsy Xywav (calcium, magnesium, potassium, and sodium oxybates) - which has been a primary treatment since 2002 and is distributed under a Risk Evaluation and Mitigation Strategy, or REMS.