DUBLIN - Avadel Pharmaceuticals plc (Nasdaq: AVDL), a company focused on transforming medicines to transform lives, today announced new and encore data supporting the clinical profile for LUMRYZ for extended-release oral suspension (CIII) and patient preference for a once-nightly oxybate in 15 poster presentations and two oral presentations, at World Sleep 2023, being held from October 20-25, 2023 in Rio de Janeiro, Brazil.

LUMRYZ (previously known as FT218), is a U.S. Food and Drug Administration (FDA) approved extended-release formulation of sodium oxybate indicated to be taken once at bedtime for the treatment of cataplexy or excessive daytime sleepiness (EDS) in adults with narcolepsy.

'We are excited to be at this year's World Sleep meeting with another robust display of data that supports both the established clinical benefit of LUMRYZ,' said Jennifer Gudeman, PharmD, Senior Vice President, Medical and Clinical Affairs of Avadel. 'Quality sleep is a foundational pillar of health for people with narcolepsy, yet 65% of patients with narcolepsy experience poor, fragmented sleep in addition to their daytime symptoms. LUMRYZ is the only FDA-approved oxybate treatment that provides clinically proven symptom improvement for excessive daytime sleepiness (EDS) or cataplexy while its novel once-at-bedtime formulation removes the need for forced awakenings to take a middle of the night oxybate dose.'

LUMRYZ has a boxed warning as a central nervous system depressant, and for its potential for abuse and misuse. LUMRYZ is available only through a restricted program under a Risk Evaluation and Mitigation Strategy called the LUMRYZ REMS. Most common adverse reactions (incidence > 5% and greater than placebo) reported for all doses of LUMRYZ combined were nausea, dizziness, enuresis, headache, and vomiting.

Highlights from the presentations include: Post-hoc analyses reinforcing data from the completed pivotal Phase 3 REST-ON trial, demonstrating that treatment with LUMRYZ resulted in statistically significant and clinically meaningful improvement in EDS as measured by the Epworth Sleepiness Scale, a patient reported outcome, with the median score in the range considered normal at the end of the study.

A poster from the open-label RESTORE study demonstrating long-term tolerability and clinically significant improvement in symptoms, including EDS, cataplexy, nighttime awakenings and severity of narcolepsy, with LUMRYZ, providing insight into its real-world use.

Two posters including new post-hoc analyses that demonstrate the robust clinical efficacy of LUMRYZ and provide further insight into the improvements on measures of EDS and cataplexy compared with placebo in different demographic and clinical subgroups based on age, sex, race, body mass index, narcolepsy subtype and alerting agent use.

A poster presenting demographic differences between patients with narcolepsy subtypes NT1 (with cataplexy) and NT2 (without cataplexy), with data from objective measures of EDS showing identical sleep latency, comparable subjective assessments of sleep quality and refreshing nature of sleep, with some other baseline parameters suggestive of more severe disease in NT1.

A poster with results from a survey of people living with narcolepsy describing their significant daytime and nighttime symptoms and primary focus on treatment of daytime symptoms in discussions between clinicians and patients, highlighting the need for comprehensive discussion and understanding of the full range of symptoms experienced by people with narcolepsy.

About LUMRYZ (sodium oxybate) for extended-release oral suspension

LUMRYZ, is an extended-release sodium oxybate medication approved by the FDA on May 1, 2023, as the first and only once-at-bedtime oxybate treatment for cataplexy or excessive daytime sleepiness (EDS) in adults with narcolepsy.

The FDA approval of LUMRYZ was supported by results from REST-ON, a randomized, double-blind, placebo-controlled, pivotal Phase 3 trial in adults with narcolepsy. LUMRYZ demonstrated statistically significant and clinically meaningful improvements in the three co-primary endpoints: EDS, clinicians' overall assessment of patients' functioning (CGI-I) and cataplexy attacks, for all three evaluated doses when compared to placebo.

With its approval, the FDA also granted seven years of Orphan Drug Exclusivity to LUMRYZ for the treatment of cataplexy or EDS in adults with narcolepsy due to a finding of clinical superiority of LUMRYZ relative to currently available oxybate treatments. In particular, the FDA found that LUMRYZ makes a major contribution to patient care over currently available, twice-nightly oxybate products by providing a once-nightly dosing regimen that avoids nocturnal arousal to take a second dose.

About Avadel Pharmaceuticals plc

Avadel Pharmaceuticals plc (Nasdaq: AVDL) is a biopharmaceutical company focused on transforming medicines to transform lives. Our approach includes applying innovative solutions to the development of medications that address the challenges patients face with current treatment options. Avadel's commercial product, LUMRYZ, was approved by the U.S. Food & Drug Administration (FDA) as the first and only once-at-bedtime oxybate for the treatment of cataplexy or excessive daytime sleepiness (EDS) in adults with narcolepsy.

Cautionary Disclosure Regarding Forward-Looking Statements

This press release includes 'forward-looking statements' within the meaning of Section 27A of the Securities Act of 1933 and Section 21E of the Securities Exchange Act of 1934. These forward-looking statements relate to our future expectations, beliefs, plans, strategies, objectives, results, conditions, financial performance, prospects or other events. Such forward-looking statements include, but are not limited to, expectations regarding the potential therapeutic benefit of LUMRYZ and the potential market preference for LUMRYZ. In some cases, forward-looking statements can be identified by the use of words such as 'will,' 'may,' 'could,' 'believe,' 'expect,' 'look forward,' 'on track,' 'guidance,' 'anticipate,' 'estimate,' 'project,' 'next steps' and similar expressions and the negatives thereof (if applicable).

The Company's forward-looking statements are based on estimates and assumptions that are made within the bounds of our knowledge of our business and operations and that we consider reasonable. However, the Company's business and operations are subject to significant risks, and, as a result, there can be no assurance that actual results and the results of the company's business and operations will not differ materially from the results contemplated in such forward-looking statements. Factors that could cause actual results to differ from expectations in the Company's forward-looking statements include the risks and uncertainties described in the 'Risk Factors' section of Part I, Item 1A of the Company's Annual Report on Form 10-K for the year ended December 31, 2022, which was filed with the Securities and Exchange Commission (SEC) on March 29, 2023, and subsequent SEC filings.

Forward-looking statements speak only as of the date they are made and are not guarantees of future performance. Accordingly, you should not place undue reliance on forward-looking statements. The Company does not undertake any obligation to publicly update or revise our forward-looking statements, except as required by law.

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