Avadel Pharmaceuticals Announces Publication of Study Data in Advances in Therapy Highlighting Need for Once-at-Bedtime Oxybate Dosing for Narcolepsy

Among 100 clinicians, the primary driver of overall oxybate choice, potential to improve patient quality of life, and decrease stress/anxiety was a single bedtime dose over the twice-nightly dosing of first-generation oxybates

DUBLIN, Ireland, June 13, 2023 (GLOBE NEWSWIRE) — Avadel Pharmaceuticals plc (Nasdaq: AVDL), a company focused on transforming medicines to transform lives, today announced the publication of survey data describing clinician preferences among oxybate treatments for patients living with narcolepsy. The paper, titled “Clinician Preferences for Oxybate Treatment for Narcolepsy: Survey and Discrete Choice Experiment,” was published in Advances in Therapy and can be accessed here.

“Sodium oxybate has been recognized as a standard of care to treat narcolepsy for more than 20 years, but, until recently, has required two nighttime doses for sufficient therapy. Data published recently demonstrate that clinicians recognize the negative impact of middle-of-the-night dosing required with twice-nightly therapies,” said Anne Marie Morse, D.O., Director of Child Neurology and Pediatric Sleep Medicine at Geisinger Medical Center at Janet Weis Children’s Hospital. “The ability to further consolidate nocturnal sleep and simplify medication regimens is extraordinarily impactful. Decreased dosing frequency was the most important attribute when considering overall product choice, improving patient quality of life, and reducing their anxiety.”

Discrete choice experiments (DCE) are studies designed to characterize and quantify drivers of preferences for attributes. Clinicians selected from hypothetical, randomly generated medicine profiles to determine which medication they preferred overall, which would improve patient quality of life, and which would reduce patient anxiety and stress. Data highlights are outlined below.

• Prior to the DCE, a survey to understand perspectives of first generation, twice-nightly oxybates, and other treatments for narcolepsy, was undertaken. Clinicians (n=100) reported moderate to high satisfaction with immediate-release oxybate treatments; however, clinicians indicated that twice-nightly dosing was a significant stressor for patients.
• In the DCE, the frequency of oxybate treatment dosing was the most important driver for overall product choice, improved patient quality of life, and reduced patient anxiety and stress; once-nightly dosing was preferred over twice-nightly.
  • The frequency of oxybate treatment dosing, driven by once-nightly dosing, was more than twice as important for overall product choice than the next two attributes, which were adverse reactions and sodium content, respectively.
  • Similarly, frequency of oxybate treatment dosing, driven by once-nightly dosing, was more than double in relative importance, for patient quality of life and for reducing patient anxiety/stress, than other attributes.
• This DCE validates a previously published DCE in patients, in which dosing frequency was also shown to be the most important driver of patients’ preferred oxybate treatment.
• These data underscore the long unmet need for an oxybate treatment that does not require middle-of-the-night dosing.

“We routinely and consistently hear from people living with narcolepsy and clinicians that there is a critical need for an effective therapy to manage cataplexy or excessive daytime sleepiness while allowing for the possibility of an uninterrupted night sleep,” said Jennifer Gudeman, PharmD, Senior Vice President, Medical and Clinical Affairs of Avadel. “These data provide insight that the most important driver of oxybate choice is dosing and not sodium content.”

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. For more information, please visit www.avadel.com.

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, statements regarding the results of the discrete choice experiment including the detail and content thereof; and expectations regarding the potential clinician preference on dosing frequency for oxybate treatments. 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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