Avadel Pharmaceuticals plc (Nasdaq: AVDL), a company focused on
transforming medicines to transform lives, today announced new data
from the completed pivotal Phase 3 REST-ON clinical trial of FT218,
also known as ON-SXB. The post-hoc data are being presented in as
two separate posters at the American College of Chest Physicians
(CHEST) annual meeting, taking place virtually October 17 – 20,
2021, along with the results of a discrete choice experiment (DCE)
to understand patient preference. FT218 is the Company’s lead drug
candidate, an investigational formulation of sodium oxybate
designed to be taken once at bedtime for the treatment of excessive
daytime sleepiness (EDS) or cataplexy in adults with narcolepsy.
FT218 is currently under review at the U.S. Food and Drug
Administration.
“The new post-hoc responder analyses demonstrating that ON-SXB
improved EDS provide further confidence in ON-SXB for people with
narcolepsy. We believe this is critical for a patient population
whose quality of life is severely impacted by EDS,” said John
Winkelman, M.D., Ph.D., presenting author, professor of Psychiatry
at Harvard Medical School and chief of the Sleep Disorders Clinical
Research Program in the Department of Psychiatry at Massachusetts
General Hospital. “These ON-SXB data represent a compelling way to
set expectations for patients receiving therapy. I believe that
ON-SXB, a once-nightly treatment option that has demonstrated
clinical benefit in a randomized controlled trial, is a meaningful
advance in treatment and, if approved, will be a welcome option for
patients and physicians alike.”
Highlights from the poster presentations are outlined below.
Sleep Latency Response with FT218, a Once-Nightly Sodium
Oxybate (ON-SXB): Post-Hoc Responder Analyses from the Phase 3
REST-ON Clinical Trial
- ON-SXB (FT218) treatment was associated with statistically
significant improvements compared to placebo on mean sleep latency,
as shown by the results of the Maintenance of Wakefulness Test, a
measure of EDS, in the pivotal Phase 3 REST-ON clinical trial:
- A significantly greater proportion of participants who received
ON-SXB compared to placebo experienced increased mean sleep latency
change from baseline ranging from ≥5 minutes to 30 minutes
- Improvement was evident as early as week 3 at the 6-g dose and
increased with the 7.5-g dose at week 8 and the 9-g dose at week
13
- The most common adverse drug reactions (≥5%) with ON-SXB 9 g
were enuresis (9.1%), dizziness (5.2%), and vomiting (5.2%)
Cataplexy Response with FT218, a Once-Nightly Sodium
Oxybate (ON-SXB): Post-Hoc Responder Analyses from the Phase 3
REST-ON Clinical Trial
- ON-SXB (FT218) treatment was associated with statistically
significant improvements compared to placebo on the number of
weekly cataplexy episodes, as shown by the results of the pivotal
Phase 3 REST-ON clinical trial:
- A significantly greater proportion of participants treated with
ON-SXB compared to placebo experienced 25%, 50% and 75% reductions
in the number of weekly cataplexy episodes with once-at-bedtime
doses of 6, 7.5, and 9 g
- Of participants taking the two highest doses (7.5 and 9 g) of
ON-SXB, approximately 10% had complete elimination of their
cataplexy, while approximately half had a 50% reduction and
one-third had a 75% reduction in their weekly cataplexy
episodes
- The most common adverse drug reactions (≥5%) with ON-SXB 9 g
were enuresis (9.1%), dizziness (5.2%), and vomiting (5.2%)
The Utility of Discrete Choice Experiment in Evaluating
Treatment Preferences Among Patients with Narcolepsy
- A discrete choice experiment evaluated drivers of patient
preference for sodium oxybate and demonstrated that dosing
frequency was the single most important attribute of a narcolepsy
treatment, with once-nightly dosing significantly more preferred
than twice-nightly dosing (P<0.001).
- The number of nightly doses was also the most important driver
observed of “taking the medication exactly as directed” and
“reduced anxiety/stress”, with once-nightly dosing preferred over
twice-nightly dosing.
“Avadel is focused on transforming medicines to transform lives,
and FT218, if approved, has the potential to be an innovative
solution for patients living with the chronic condition of
narcolepsy,” said Jennifer Gudeman, PharmD, Vice President of
Medical and Clinical Affairs at Avadel. “FT218 has demonstrated
meaningful improvement in cataplexy attacks and measurements of EDS
with a dosing regimen preferred by patients. We believe in
listening to patients to deliver solutions that improve their
symptoms and look forward to our ongoing partnership with the
narcolepsy community as we strive to make FT218 available to
patients and prescribers.”
Avadel also presented encore posters featuring post hoc analyses
from the REST-ON trial at the annual meeting of the American
Neurological Association, taking place virtually October 17 – 19,
2021, which affirmed the clinical benefit of FT218 on EDS,
regardless of narcolepsy subtype (NT1, with cataplexy and NT2,
without cataplexy) and with or without concomitant stimulant use,
while also demonstrating a modest reduction in weight and body mass
index over the 13-week trial.
About FT218FT218 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 excessive daytime sleepiness (EDS) or cataplexy in
adults with narcolepsy.
In March 2020, Avadel completed the REST-ON study, a randomized,
double-blind, placebo-controlled, pivotal Phase 3 trial, to assess
the efficacy and safety of FT218 in adults with narcolepsy. Among
the three co-primary endpoints, FT218 demonstrated statistically
significant and clinically meaningful results in EDS, the
clinician’s overall assessment of the patient’s functioning, and
reduction in cataplexy attacks, for all three evaluated does when
compared to placebo.
In January 2018, the U.S. Food and Drug Administration (FDA)
granted FT218 Orphan Drug Designation for the treatment of
narcolepsy based on the plausible hypothesis that FT218 may be
clinically superior to the twice-nightly formulation of sodium
oxybate already approved by the FDA for those with narcolepsy due
to the consequences of middle-of-the-night dosing of the approved
product. FT218 is currently under review by the FDA.
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, FT218, 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 excessive daytime sleepiness and
cataplexy 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, our
expectations of the therapeutic benefits of FT218, the timing of
the FDA’s review of our NDA for FT218, the sufficiency of data
supporting our NDA for FT218, the commercial launch of FT218 (if
approved), and the market acceptance of FT218 (if approved). 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).
Our 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,
our business and operations are subject to significant risks, and,
as a result, there can be no assurance that actual results and the
results of our 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 our forward-looking statements include the risks and
uncertainties described in the “Risk Factors” section of Part I,
Item 1A of our Annual Report on Form 10-K for the year ended
December 31, 2020, which we filed with the Securities and Exchange
Commission on March 9, 2021 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. We
do not undertake any obligation to publicly update or revise our
forward-looking statements, except as required by law.
Contacts:
Investor Contact:Courtney TurianoStern Investor
Relations, Inc. Courtney.Turiano@sternir.com (212) 698-8687
Media Contact:Nicole Raisch GoelzReal
Chemistryngoelz@realchemistry.com(408) 568-4292
Avadel Pharmaceuticals (NASDAQ:AVDL)
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