AVDL - Avadel stock rises 8% as FDA grants tentative approval to its Jazz's sleep disorder drug rival

The U.S. Food and Drug Administration (FDA) granted tentative approval to Avadel Pharmaceuticals' ( NASDAQ: AVDL ) Lumryz to treat excessive daytime sleepiness (EDS) or cataplexy in adults with narcolepsy.

The company said the final approval for Lumryz, also known as FT218, is pending disposition of a U.S. patent, No. 8,731,963  (the 'REMS patent').

The patent in question was granted to Jazz Pharmaceuticals' ( NASDAQ: JAZZ ) drug Xyrem which is approved and being sold for the same use.

REMS (Risk Evaluation and Mitigation Strategy) according to the FDA is a drug safety program that the agency can require for certain medications with serious safety concerns to help ensure the benefits of the therapy outweigh its risks. While all drugs have labeling, only a few medications require a REMS.

The '963 patent allegedly covered using a computer-implemented system which addressed certain FDA-required REMS conditions of using Xyrem as per the label, according to a report by JD Supra.

Avadel said in a July 19 press release that it has filed a motion in the U.S. District Court for the District of Delaware on June 23, to delist the REMS patent from FDA’s Orange Book.

The company added that the tentative approval suggests that Lumryz met all required quality, safety, and efficacy standards necessary for approval in the U.S.

"Tentative approval is an important regulatory step forward and indicates LUMRYZ could potentially be granted final approval in 11 months or less," said Avadel CEO Greg Divis.

In May, the company said that the FDA noted that the FT218 NDA patent statement related to the REMS patent was deemed inappropriate by the agency. The FDA also asked the company to add a certification to the REMS patent to its NDA.

AVDL +8.18% premarket to $4.63

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