The US Food and Drug Administration (FDA) has approved Pre-Launch Activities Importation Requests (PLAIR) for Avadel Pharmaceuticals’ Lumryz (sodium oxybate), a tentatively-approved drug to treat cataplexy or excessive daytime sleepiness in adults with narcolepsy.
Avadel is now authorized to import the unapproved drug product into the US ahead of its anticipated final approval to prepare for market launch. By importing Lumryz into the US before anticipated final approval, Avadel is able to shorten the time to product availability following a decision by the FDA, according to a press release by the company.
“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,” says Greg Divis, Avadel Pharmaceuticals CEO, in a press release. “We remain committed to working collaboratively with FDA to bring Lumryz to people living with narcolepsy.”
The FDA tentatively approved Lumryz in July 2022. Avadel submitted a minor amendment to the FDA on March 1, requesting final approval of Lumryz.
Avadel is currently evaluating the long-term safety and tolerability of Lumryz, designed to be taken once at bedtime, in the open-label RESTORE clinical study.