Avadel Pharmaceuticals Announces Publication of Study Data in Advances in Therapy Highlighting Need for Once-at-Bedtime Oxybate Dosing for Narcolepsy
13 Juin 2023 - 2:00PM
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
plcAvadel 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 StatementsThis 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.
Investor Contact:Courtney
TurianoStern Investor Relations, Inc. Courtney.Turiano@sternir.com
(212) 698-8687
Media Contact:Natalie RubinoReal
Chemistrynrubino@realchemistry.com
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