Avadel Pharmaceuticals Announces Publication of Real-World Data Highlighting the Risk of Accidental Dosing Errors with Immediate-Release Twice-Nightly Oxybates
24 1월 2023 - 10:00PM
Avadel Pharmaceuticals plc (Nasdaq: AVDL), a biopharmaceutical
company focused on transforming medicines to transform lives, today
announced the publication of real-world data describing the risk of
accidental dosing errors with immediate-release twice-nightly
oxybate. The paper, titled “Evidence of Accidental Dosing Errors
with Immediate-Release Sodium Oxybate: Data From the US Food and
Drug Administration Adverse Event Reporting System,” was published
in Drugs — Real World Outcomes and can be accessed here.
Oxybates are currently available as a twice-nightly formulation,
which requires patients with narcolepsy, who already struggle with
uneven and interrupted sleep, to take a first dose at bedtime and
the second dose 2.5-4 hours later.1,2 Due to the inherent risk of
accidental mistakes from this dosing schedule, an analysis was
conducted on post-marketing safety surveillance data from the U.S.
Food and Drug Administration (FDA) Adverse Event Reporting System
(FAERS) to identify reports of suspected dosing errors. Data
highlights are outlined below.
- Out of 541 reports where the second dose of an
immediate-release twice-nightly oxybate may not have been taken as
prescribed, 177 were submitted as serious reports and subsequently
analyzed, including:
- Accidental early administration of the second dose resulting in
adverse events (AEs; n=41)
- “Near miss” with no harm reported following early dosing
(n=9)
- Intentionally taking second dose early (n=25)
- Other inappropriate use, such as late dosing or not taking
daily (n=102)
- Among the 41 reports of taking the second dose too early
resulting in AEs:
- 22% (9/41) used emergency services and 27% (11/41) resulted in
hospitalizations
- AEs reported with accidentally taking the second dose too early
included CNS depression, bradycardia, respiratory depression,
dizziness, seizure, confusion, delirium, difficulty awakening,
drowsiness, falls, nausea, vomiting and enuresis
- 20% of accidental early administration cases took their two
doses at or almost at the exact same time; 39% consumed their
second dose of immediate-release sodium oxybate oral solution less
than 1 hour after the first dose; 61% took the second dose between
1 and 2.5 hours after the first dose
- There was a greater frequency of reported harm to patients in
the group who took their second dose 1 hour or less after their
first dose
- Currently, there is no information pertaining to the risk of
accidentally consuming the second dose less than 2.5 hours after
the first dose or related potential patient harm in the labeling
for the marketed immediate-release twice-nightly oxybate
products2,3
“Post-marketing adverse event reports are recognized to
represent just the ‘tip of the iceberg’ as reporting is voluntary
for patients and clinicians and likely underestimates
incidence3,4,” said Jennifer Gudeman, PharmD., Senior Vice
President, Medical and Clinical Affairs of Avadel. “This analysis
identified and described serious reports due to patients
accidentally consuming their second, middle-of-the-night
immediate-release sodium oxybate dose less than 2.5 hours after the
first dose. Nearly one-fourth of these cases resulted in
emergency medical services or emergency department visits, and
another 27% resulted in hospitalization. The medical and patient
community should be aware of this risk with immediate-release
oxybates, as it is not currently described in the labeling. An
extended-release once-nightly sodium oxybate product that
eliminates a second, middle-of-the-night dose, could potentially
mitigate these risks.”
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. Our current lead drug candidate is an
investigational formulation of sodium oxybate leveraging our
proprietary drug delivery technology and designed to be taken once
at bedtime for the treatment of cataplexy or 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, the
potential mitigation of adverse events by a single dose,
once-nightly oxybate product. 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, 2021, which was filed with the Securities and Exchange
Commission (SEC) on March 16, 2022, 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:Gabriella GreigReal
Chemistryggreig@realchemistry.com(203)
249-2688
References:1
https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/021196s030lbl.pdf.
Accessed 20 January 2023. 2
https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/212690s000lbl.pdf.
Accessed 20 January 2023. 3 Ahmad, SR. “Adverse drug event
monitoring at the Food and Drug Administration”. J Gen Intern Med,
vol. 18, no. 1, 2003, pp. 57-60. doi:
10.1046/j.1525-1497.2003.20130.x.4 Amran, S. “Adverse Drug
Reactions and Pharmacovigilance”. New Insights into the Future of
Pharmacoepidemiology and Drug Safety, 2021. doi:
10.5772/intechopen.98583
Avadel Pharmaceuticals (NASDAQ:AVDL)
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Avadel Pharmaceuticals (NASDAQ:AVDL)
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부터 10월(10) 2023 으로 10월(10) 2024