Avadel Pharmaceuticals plc (Nasdaq: AVDL), a biopharmaceutical company dedicated to improving lives through innovative medicines, is pleased to announce that the U.S. Food and Drug Administration (FDA) has granted approval of its Pre-Launch Activities Importation Requests (PLAIR) for LUMRYZ. This marks an important milestone for the company and its commitment to making the future of medicine brighter for patients and their families.
Avadel is taking full advantage of its PLAIR authorization to bring the unapproved drug product LUMRYZ to the U.S. before its anticipated final approval. By importing the product before its final approval, Avadel is able to reduce the time necessary to bring the drug to market after receiving the FDA’s final decision. This is a great way to get ahead of the game and give consumers access to the drug as soon as possible.
Avadel Pharmaceuticals is thrilled to announce that the FDA has granted the company’s PLAIR request to import LUMRYZ, a potential treatment for narcolepsy. This approval will enable Avadel to expedite the process of providing LUMRYZ to patients in need. According to Chief Executive Officer Greg Divis, “We remain committed to working collaboratively with FDA to bring LUMRYZ to people living with narcolepsy.” With this approval, Avadel is one step closer to helping those affected by narcolepsy.
LUMRYZ is a revolutionary formulation of sodium oxybate that utilizes our cutting-edge drug delivery technology. Developed to help adults with narcolepsy manage cataplexy or excessive daytime sleepiness (EDS), LUMRYZ is designed to be taken as a single dose at bedtime. With its innovative approach, LUMRYZ may be the solution that those suffering from narcolepsy have been waiting for.
Avadel has completed the REST-ON study, a groundbreaking Phase 3 clinical trial assessing the efficacy and safety of LUMRYZ in narcolepsy patients. Results revealed that LUMRYZ significantly reduced excessive daytime sleepiness, improved functioning, and reduced cataplexy attacks compared to placebo for all three evaluated doses. These findings are both statistically and clinically significant, offering a potential new treatment option for those living with narcolepsy.
In January 2018, the U.S. Food and Drug Administration granted LUMRYZ Orphan Drug Designation for the treatment of narcolepsy. This groundbreaking designation was awarded due to the potential safety benefits associated with the product, which is being reviewed by the FDA.
LUMRYZ offers a unique solution to the twice-nightly dosing regimen of sodium oxybate already approved by the FDA, providing hope for a new and more effective treatment for narcolepsy.
On July 18, 2022, Avadel’s application for the approval of LUMRYZ to treat cataplexy or EDS in adults with narcolepsy was tentatively accepted by the FDA. Following this, on March 1, 2023, Avadel submitted a minor amendment to the FDA, requesting the final approval of LUMRYZ.
This request came shortly after the United States Court of Appeals for the Federal Circuit ruled unanimously in favor of delisting the REMS Patent from FDA’s Orange Book by Jazz Pharmaceuticals, following a 3-0 panel decision on February 24.
Do you have an NDA, ANDA, or CDER-regulated BLA awaiting an FDA decision? PLAIR is here to help! We can provide permission to import an unapproved finished dosage form drug product for reconditioning in anticipation of your FDA application approval. PLAIR is not a guarantee of approval, but it makes the process of getting ready for market launch easy and stress-free.