Avadel Pharmaceuticals plc (Nasdaq: AVDL), a company focused on
developing FT218, an investigational, once-nightly formulation of
sodium oxybate for treating excessive daytime sleepiness and
cataplexy in adults with narcolepsy, today announced new post hoc
analyses of data from the completed pivotal Phase 3 REST-ON
clinical trial of FT218. The data were presented in three separate
posters at SLEEP 2021, the 35th Annual Meeting of the Associated
Professional Sleep Societies (APSS), a joint meeting of the
American Academy of Sleep Medicine and the Sleep Research Society.
FT218 is currently under review at the U.S. Food and Drug
Administration (FDA) with a Prescription Drug User Fee Act (PDUFA)
target date of October 15, 2021.
“For the past 20 years, the standard of care for narcolepsy has
been a twice-nightly medication, a challenging dosing regimen that
disrupts nighttime sleep. The new data from the REST-ON trial
demonstrate that the once-nightly formulation of sodium oxybate
taken at bedtime was effective in addressing the symptoms of
narcolepsy without requiring the patient to wake up in the middle
of the night,” said Asim Roy, M.D., trial investigator and medical
director of the Ohio Sleep Medicine Institute. “The new data
analyses showing that FT218 improved excessive daytime sleepiness
in patients with narcolepsy, both with and without cataplexy,
regardless of stimulant use, are important for this patient
population. Moreover, the data demonstrating a reduction in weight
is an added benefit for narcolepsy patients, who tend to be
overweight. I am encouraged by these and other data and believe
FT218, if FDA approved, will be an important once-nightly treatment
option for people who struggle with managing narcolepsy.”
Highlights from the poster presentations are outlined below.
Efficacy of FT218, a Once-Nightly Sodium Oxybate
Formulation, by Narcolepsy Subtype: A Post Hoc Analysis from the
REST-ON Study
- FT218 demonstrated statistically significant improvement in
excessive daytime sleepiness (EDS) at all evaluated doses in
patients with narcolepsy subtypes 1 (NT1, with cataplexy) and 2
(NT2, without cataplexy), with greater improvement in measures of
EDS, including mean sleep latency on maintenance of wakefulness
test (MWT) and Clinical Global Impression-Improvement (CGI-I) in
overall condition, compared to placebo.
- The least squares (LS) mean difference in mean sleep latency
(in minutes) on MWT between FT218 and placebo was 6.0 for 9 g (week
13), 7.0 for 7.5 g (week 8), and 4.9 for 6 g (week 3) in NT1
patients (all p<0.001), and 6.3 for 9 g (P<0.05), 4.0 for 7.5
g (P=NS), and 5.3 for 6 g (P<0.05) in NT2 patients.
- A significantly greater percentage of patients with NT1
receiving FT218 were rated as much or very much improved on the
CGI-I compared to placebo: 75.5% vs. 35.9% at 9 g, 66.9% vs. 27.9%
at 7.5 g, and 39.9% vs. 7.8% at 6 g (all P<0.001). A greater
percentage of NT2 patients receiving FT218 were rated as much/very
much improved at all three doses vs. placebo.
Efficacy of FT218, a Once-Nightly Sodium Oxybate
Formulation, by Stimulant Use: A Post Hoc Analysis from the REST-ON
Study
- FT218 demonstrated statistically significant improvement in EDS
at all evaluated doses in narcolepsy patients with or without
stimulant use, with improvement over placebo on MWT and CGI-I.
- The LS mean difference in mean sleep latency (in minutes) on
MWT between FT218 and placebo was 6.0 for 9 g (week 13), 5.5 for
7.5 g (week 8), and 5.4 for 6 g (week 3) for patients with
concomitant stimulant use (all P≤0.001). For patients not taking
stimulants, the LS mean difference was 6.3 for 9 g (P=0.001), 7.1
for 7.5 g (P<0.001), and 4.2 for 6 g (P<0.01).
- More patients receiving FT218 were rated much/very much
improved on CGI-I compared to placebo: 80.5% vs. 35.3% at 9 g,
66.3% vs. 26.5% at 7.5 g, and 39.8% vs. 4.4% at 6 g for patients
with stimulant use (all P<0.001); 55.1% vs. 27.2% at 9 g
(P<0.05), 54.5% vs. 17.5% at 7.5 g (P=0.006), and 40.0% vs. 7.7%
at 6 g (P<0.01) for patients without stimulant use.
Weight Loss with FT218, a Once-Nightly Sodium Oxybate
Formulation for the Treatment of Narcolepsy: Post Hoc Analysis from
REST-ON
- Patients receiving FT218 experienced a significantly greater
decrease in weight and body mass index (BMI) from baseline to study
end (week 13) compared to placebo.
- At study end, the mean (SD) change in weight from baseline was
–1.3 (3.6) kg for patients receiving FT218 compared to 0.2 (2.6) kg
for patients receiving placebo. Overall, 17.8% of patients
receiving FT218 compared to 3.8% of patients receiving placebo
experienced ≥5% weight loss.
- At study end, the LS mean (SE) change in BMI from baseline was
‒0.5 (0.13) kg/m2 for patients receiving FT218 and 0.1 (0.13) kg/m2
for patients receiving placebo (P=0.001).
“Avadel is focused on providing a meaningful solution for people
with narcolepsy and we are pleased to share further evidence of the
clinical benefit of FT218, taken once at bedtime,” said Jennifer
Gudeman, PharmD, Vice President of Medical and Clinical Affairs at
Avadel. “We leveraged our unique scientific capabilities to develop
a proprietary formulation of sodium oxybate to address the
limitations of currently available treatments that require
twice-nightly dosing. We believe these new analyses, along with
previously presented REST-ON positive Phase 3 data, strengthen the
body of evidence demonstrating that FT218, if approved, has the
potential to be a transformative treatment for people living with
narcolepsy.”
Previously released results from the REST-ON trial demonstrated
highly statistically significant (p<0.001 compared to placebo)
and clinically meaningful improvement across all three co-primary
endpoints (MWT, CGI-I and mean weekly cataplexy attacks) with FT218
at 6, 7.5 and 9 g. Secondary endpoint data for FT218 taken once at
bedtime demonstrated clinically meaningful results at all tested
doses, for reducing disturbed nocturnal sleep; additional post hoc
analyses further demonstrated significant increase in time in deep
sleep, and significant decrease in light sleep compared to placebo
for doses evaluated beginning by week 3 with only a 6-g-dose. As
reported at the American Academy of Neurology 2021 meeting, FT218
also demonstrated a significant improvement in the Epworth
Sleepiness Scale, a patient reported outcome, and significantly
improved patient perceptions of the quality and refreshing nature
of sleep at all doses tested beginning by week 3. FT218 taken once
at bedtime at 9 g was generally well tolerated with commonly known
sodium oxybate adverse reactions occurring at low rates. These
findings will also be presented by Avadel at SLEEP 2021 in an oral
and poster session (abstract # 488) and two additional posters
(abstract # 489 and 490).
The Company is also hosting a virtual medical booth that houses
the posters, an on-demand symposium titled “How Narcolepsy
Management Is Evolving: Expert Panel Discussion,” and detailed
information about its ongoing research and publications. The
virtual medical booth can be accessed at
http://www.sleep2021.avadelmedicalbooth.com/ until November 30,
2021.
About FT218FT218 is an investigational,
once-nightly formulation of sodium oxybate that includes Avadel’s
MicroPump™ controlled-release (CR) technology. In March of 2020,
the Company completed the REST-ON study, a pivotal, double-blind,
randomized, placebo-controlled Phase 3 trial, to assess the
efficacy and safety of FT218 in the treatment of excessive daytime
sleepiness and cataplexy in patients suffering from narcolepsy. In
December 2020, the Company submitted a New Drug Application (NDA)
to the U.S. Food and Drug Administration (FDA) for FT218 to treat
excessive daytime sleepiness and cataplexy in adults with
narcolepsy. The NDA for FT218 was accepted by the FDA in February
2021 and assigned a Prescription Drug User Fee Act (PDUFA) target
action date of October 15, 2021. FT218 has been granted Orphan Drug
Designation from the U.S. Food and Drug Administration (FDA) for
the treatment of narcolepsy. The designation was granted on the
plausible hypothesis that FT218 may be clinically superior to the
twice-nightly formulation of sodium oxybate already approved by the
FDA for the same indication. In particular, FT218 may be safer due
to ramifications associated with the dosing regimen of the
previously approved product.
About Avadel Pharmaceuticals plcAvadel
Pharmaceuticals plc (Nasdaq: AVDL) is a biopharmaceutical
company primarily focused on the development and U.S. Food and Drug
Administration (FDA) approval of FT218, an investigational,
once-nightly, extended-release formulation of sodium oxybate
designed to treat 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 the Company’s 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 tolerability or therapeutic benefits of
FT218, the timing of the FDA’s review of the NDA for FT218, the
sufficiency of data supporting the 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).
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 risk that positive results
from the REST-ON trial may not necessarily be predictive of the
results of future or ongoing clinical studies; the risk that the
NDA for FT218 is not approved by the FDA or such approval is
delayed; the risk that FT218 (if approved) may not receive a 7-year
Orphan Drug Exclusivity; the risk that commercial launch of FT218
(if approved) is delayed or never occurs; the risk that the
potential market performance for FT218 (if approved) may differ
materially from projections; and the risk that the impact of the
current COVID-19 pandemic on the Company’s financial results and
results of operations could be greater than we anticipate and 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, 2020, which was filed with
the Securities and Exchange Commission (SEC)
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. The
Company does 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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