Avadel Pharmaceuticals plc (Avadel) operates as a biopharmaceutical company.
LUMRYZ is an extended-release formulation of sodium oxybate indicated to be taken once at bedtime for the treatment of cataplexy or EDS in patients seven years of age and older with narcolepsy. As of December 2024, LUMRYZ is the only commercial product in the company’s portfolio.
LUMRYZ
LUMRYZ was approved by the U.S. Food and Drug Administration (FDA) on May 1, 2023, for the treatment of cataplexy or EDS in adults w...
Avadel Pharmaceuticals plc (Avadel) operates as a biopharmaceutical company.
LUMRYZ is an extended-release formulation of sodium oxybate indicated to be taken once at bedtime for the treatment of cataplexy or EDS in patients seven years of age and older with narcolepsy. As of December 2024, LUMRYZ is the only commercial product in the company’s portfolio.
LUMRYZ
LUMRYZ was approved by the U.S. Food and Drug Administration (FDA) on May 1, 2023, for the treatment of cataplexy or EDS in adults with narcolepsy. The FDA also granted seven years of Orphan Drug Exclusivity (‘ODE’) to LUMRYZ for the treatment of cataplexy or EDS in adults with narcolepsy due to a finding of clinical superiority of LUMRYZ relative to marketed oxybate treatments. In particular, the FDA found that LUMRYZ makes a major contribution to patient care over marketed, twice-nightly oxybate treatments by providing a once-nightly dosing regimen that avoids nocturnal arousal to take a second dose. In June 2023, the company announced the U.S. commercial launch of LUMRYZ for the treatment of cataplexy or EDS in adults living with narcolepsy. LUMRYZ was approved by the FDA for use in the treatment of cataplexy or EDS in the pediatric narcolepsy population seven years of age and older on October 16, 2024, and was granted ODE for this patient population through October 16, 2031.
Under the LUMRYZ REMS, healthcare providers who prescribe the drug must be specially certified, pharmacies that dispense the drug must be specially certified, and the drug must be dispensed only to patients who have enrolled in the LUMRYZ REMS and completed all Risk Evaluation and Mitigation Strategy (REMS) requirements, including documentation of safe use conditions.
The company has 30 U.S. patents listed for LUMRYZ in FDA’s Orange Book. With respect to clinical data generated for LUMRYZ, it conducted a Phase 3 clinical trial of LUMRYZ (the ‘REST-ON trial’), which was a randomized, double-blind, placebo-controlled study that enrolled patients who received at least one dose of LUMRYZ or placebo, and was conducted in clinical sites in the U.S., Canada, Western Europe and Australia.
Additionally, the company’s open-label extension/switch study of LUMRYZ (‘RESTORE’) examined the long-term safety and maintenance of efficacy of LUMRYZ in patients with narcolepsy who participated in the REST-ON trial, as well as dosing and preference data for patients who switched from twice-nightly sodium oxybate to once-at-bedtime LUMRYZ, regardless of whether they participated in the REST-ON trial.
Avadel has initiated a pivotal trial in IH, REVITALYZ, which is a double-blind, placebo-controlled, randomized withdrawal, multicenter Phase 3 study designed to evaluate the efficacy and safety of LUMRYZ, in treating IH.
Drug Delivery Technologies
The company owns drug delivery technologies that address formulation challenges, potentially allowing the development of differentiated drug products for administration in various forms (e.g., capsules, tablets, powders or liquid for oral use; or injectables for subcutaneous administration) that could be applied to a broad range of drugs.
A brief discussion of each of the company’s drug delivery technologies is set forth below.
MICROPUMP
The company’s MICROPUMP technology allows for the development of modified release solid, oral dosage formulations of drugs. A version of the company’s MICROPUMP technology is being employed in LUMRYZ.
LIQUITIME
The company’s LIQUITIME technology allows for the development of modified release oral products in a liquid suspension formulation.
MEDUSA
The company’s MEDUSA technology allows for the development of modified-release injectable dosage formulations of drugs (e.g., peptides, polypeptides, proteins, and small molecules).
Intellectual Property
Numerous LUMRYZ-related U.S. patents have been issued having expiration dates spanning from mid-2037 to early-2042, and there are additional patent applications in development and/or pending at the USPTO, as well as foreign patent offices.
Government Regulation
LUMRYZ is subject to regulation by the U.S. Drug Enforcement Administration (“DEA”) under the Controlled Substances Act (“CSA”), and its manufacturing and distribution are highly restricted.
The API in LUMRYZ, sodium oxybate, is a Schedule I controlled substance in the U.S., and the FDA-approved LUMRYZ product is a Schedule III controlled substance in the U.S.
In addition, the third parties who perform the company’s clinical and commercial manufacturing, distribution, dispensing and clinical studies for LUMRYZ are required to maintain necessary the U.S. Drug Enforcement Administration (DEA) registrations and state licenses.
History
The company was incorporated in 2015. It was formerly known as Flamel Technologies SA and changed its name to Avadel Pharmaceuticals plc in 2017.