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What makes LUMRYZ a major contribution to patient care?

The FDA found once-nightly dosing promotes normal nighttime sleep.1

MAJOR CONTRIBUTION TO PATIENT CARE2

FDA, MAY 2023

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The benefits of LUMRYZ once-nightly dosing rise to the level of making a major contribution to patient care because LUMRYZ dosing provides for oxybate therapy that DOES NOT INVOLVE DISRUPTING OR FRAGMENTING SLEEP…

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…Whereas Xyrem and Xywav necessitate a nocturnal awakening to take a second dose, which DISRUPTS SLEEP ARCHITECTURE IN PATIENTS WITH A KNOWN SLEEP DISORDER.

Aside from the medical benefits of not having to awaken to take a second dose, it is inherently MORE CONVENIENT, EASIER, AND LESS BURDENSOME for patients to forgo awakening to take a second dose on a nightly basis.2

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—FDA Clinical Superiority Findings, May 2023

Due to these findings, the FDA has determined LUMRYZ dosing to be clinically superior* to twice-nightly oxybates.

Importantly, this is in the context of a chronic neurological condition that requires potentially lifelong treatment.1,2

—FDA Clinical Superiority Findings, May 2023*

*Based on a determination of Orphan Drug Exclusivity by the FDA Office of Orphan Products Development between LUMRYZ and XYREM or XYWAV. There are no head-to-head data for LUMRYZ and XYREM or XYWAV.

The FDA defines a “clinically superior” drug as one “shown to provide a significant therapeutic advantage over and above that provided by an approved orphan drug (that is otherwise the same drug)” in 1 of 3 ways3:

  1. Greater effectiveness
  2. Greater safety
  3. Major contribution to patient care

If the Office of Orphan Products Development (OOPD) determines a drug fits within 1 of these categories, they have the power to grant clinical superiority status without the use of a head-to-head clinical trial.3

XYWAV was granted ODE status at a time when XYREM® (sodium oxybate) was the only other oxybate available. The FDA determined that “XYWAV is clinically superior to XYREM” because it has significantly less sodium.3

LUMRYZ once-at-bedtime dosing was granted ODE status on May 1, 2023, because the FDA determined it to be clinically superior to both XYREM and XYWAV twice-nightly oxybates on the basis of being a major contribution to patient care.3

References:

  1. References: 1. Avadel, Data on file. 2. US Food and Drug Administration. Clinical superiority findings. https://www.fda.gov/industry/designating-orphan-product-drugs-and-biological-products/clinical-superiority-findings#644fe8ebd4a58 3. Office of Orphan Products Development Food and Drug Administration. Re: Determination that Xywav’s (NDA 212690) unexpired orphan-drug exclusivity (“ODE”) does not block approval of Lumryz (NDA 214755). Silver Spring, MD; May 1, 2023. 1-132.