AVDL - Avadel stock rises on FDA nod to import sleep disorder drug Lumryz ahead of potential approval

2023-03-22 07:27:14 ET

The U.S. Food and Drug Administration (FDA) approved Avadel Pharmaceuticals' ( NASDAQ: AVDL ) pre-launch activities importation requests (PLAIR) for sleep disorder therapy Lumryz.

Through the PLAIR, Avadel is authorized to import unapproved drug product into the U.S. ahead of expected final approval of the tentatively approved Lumryz NDA, to prepare for market launch.

The Irish company said that by importing the drug early it will be able to shorten the time to product availability after a final approval decision by the FDA.

The FDA has already granted tentative approval for Lumryz. Earlier in March, Avadel submitted an amendment to the FDA requesting final approval for Lumryz to treat cataplexy or excessive daytime sleepiness (EDS) in adults with narcolepsy.

Avadel went for final FDA approval after Jazz Pharma ( NASDAQ: JAZZ ) lost an appeal related to a patent dispute. Jazz, which markets Xyrem for the same indication, had disputed the IP rights for Lumryz based on a U.S. patent No. 8731963 (REMS Patent).

"The granting of our PLAIR request by the FDA followed the submission of our amendment requesting a final approval decision for LUMRYZ. The approval to import LUMRYZ comes at an important time for Avadel as the availability of commercial supply allows us to further shorten the timeline between a potential approval and being able to provide LUMRYZ to patients," said Avadel CEO Greg Divis.

AVDL +6.48% to $8.55 premarket March 22

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