The final approval, which was sought by Avadel Pharmaceuticals in March this year, was granted based on the positive data from the REST-ON phase 3 clinical trial
LUMRYZ is an extended-release formulation of sodium oxybate. (Credit: Abbie Bernet on Unsplash)
Avadel Pharmaceuticals has secured the final approval from the US Food and Drug Administration (FDA) for LUMRYZ for the treatment of cataplexy or excessive daytime sleepiness (EDS) in adults with narcolepsy.
LUMRYZ is an extended-release formulation of sodium oxybate intended to be consumed once at bedtime. It has also received orphan drug exclusivity from the FDA.
LUMRYZ is now the first and only once-at-bedtime oxybate to be approved so far by the FDA for people having narcolepsy.
The final approval, which was sought by Avadel Pharmaceuticals in March this year, was granted based on the positive data from the phase 3 REST-ON clinical trial. The late-stage trial was finished in March 2020.
According to the findings, the sodium oxybate formulation showed highly statistically significant and clinically meaningful improvement in comparison to placebo across all three co-primary endpoints.
The trial assessed 6, 7.5, and 9gm of the once-at-bedtime investigational formulation of sodium oxybate.
Avadel Pharmaceuticals CEO Greg Divis said: “Today’s landmark approval and receipt of Orphan Drug Exclusivity represents a major milestone for both Avadel and people living with narcolepsy.
“As we have heard from key stakeholders, previously approved narcolepsy therapies have the potential to disrupt sleep by either causing insomnia or through forced awakening during the middle of the night for their crucial second dose.
“LUMRYZ can now offer people with narcolepsy the opportunity for an uninterrupted night sleep while receiving the full benefit of their prescribed treatment in one single bedtime dose that addresses their symptoms of narcolepsy.”
Additionally, FDA found LUMRYZ to be clinically superior to existing twice-nightly oxybate products and thereby granted it seven years of orphan drug exclusivity.
The US health regulator found that the drug supports patient care against currently available, twice-nightly oxybate products by offering a once-nightly dosing regimen that avoids nocturnal arousal for taking another dose.