The U.S. Food and Drug Administration (FDA) has granted tentative approval to Avadel Pharmaceuticals’ AVDL lead candidate LUMRYZ (FT218) for the treatment of excessive daytime sleepiness (EDS) or cataplexy in adults with narcolepsy.
The tentative approval indicates that LUMRYZ has met all required quality, safety, and efficacy standards necessary for approval in the U.S. Final approval is pending disposition of U.S. Patent.
Greg Divis, Chief Executive Officer, commented : “We have reached a critical milestone, as tentative approval confirms the safety profile and clinical efficacy of LUMRYZ for adults with narcolepsy. Tentative approval is an important regulatory step forward and indicates LUMRYZ could potentially be granted final approval in 11 months or less. We believe once-at-bedtime LUMRYZ offers the opportunity to positively transform the lives of oxybate eligible patients living with narcolepsy. “
The company is pursuing strategies to accelerate final approval.
Price Action : Avadel shares are trading around 10 percent higher at $4.69 on Tuesday during pre-market session.
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