Avadel’s enrolment completion in its trial for IH, to raise hope among the IH patient group

Announcement

Avadel Pharmaceuticals plc, a leading biopharmaceutical company targeting transforming medicines to add value to the patient's quality of life, has declared its completion of the patient enrolment in REVITALYZ. It’s a Phase 3 trial examining LUMRYZ™ (sodium oxybate), focusing on proving the extended-release oral suspension as a potent, ideal treatment for idiopathic hypersomnia (IH).

About REVITALYZ

The REVITALYZ is a reliable, shuffled, placebo balanced withdrawl, centric Phase 3 trial engineered to assess the safety and efficacy of LUMRYZ. This drug is dosed once at bedtime, once in IH. The trial is examining the study candidates who are hopping from quick-release oxybates and those who are not taking any oxybates.

The FCCP, FAASM, M.D., Principal of Bogan Sleep Consultants, LLC, and Associate Clinical Professor at the University of South Carolina School of Medicine, Richard K. Bogan, said, “Idiopathic hypersomnia is a radically undeserved and extremely serious sleep disorder, measured as a serious impact on the sleep cycle that puts hurdles in waking up. It’s known as sleep inertia that promotes daytime sleepiness.”

“The people suffering and struggling with IH require additional treatments. With a therapeutic dose engineered to encompass the nocturnal sleep period because of its extension realese formulation, the LUMRYZ can become a healing solution. It can be an ideal and effective option if received an approval for the IH patient group.”

The first objective of REVITALYZ is to illustrate the control in daytime sleepiness as per the primary endpoint analysis that detects the change in overall score in Week 14 on the Epworth Sleepiness Scale (ESS). The secondary endpoint will assess the positive impact of LUMRYZ on the additional efficacy line. The line involves clinician and patient impression, a reaction to change, calculation of the functional results of sleep and severity of the idiopathic hypersomnia.

The PharmD, Senior Vice President of Medical and Clinical Affairs at Avadel Pharmaceuticals, Jennifer Gudeman, said, “This successful completion of enrolment in the REVITALYZ trial represents a crucial step towards the betterment of the IH community. The clinical advantages of LUMRYZ have shown impressive results among the narcolepsy community.”

“Following this, we are confident about our extended-release sodium oxybate that holds the ability to be a significant treatment for the IH population upon FDA approval. We are grateful to the investigators and patients who enrolled and trusted us with REVITALYZ for advancing this fundamental research.”