Avadel Pharmaceuticals Announces Publication of Data from Pivotal Phase 3 REST-ON Trial of FT218 in Adults with Narcolepsy in SLEEP
16 8월 2021 - 9:00PM
Avadel Pharmaceuticals plc (Nasdaq: AVDL), a company focused on
developing FT218, an investigational, once-nightly formulation of
sodium oxybate for treating excessive daytime sleepiness (EDS) and
cataplexy in adults with narcolepsy, announced today the
publication of data from its pivotal Phase 3 REST-ON trial of FT218
in SLEEP, the journal of the Sleep Research Society. The paper,
titled “Once-Nightly Sodium Oxybate (FT218) Demonstrated
Improvement of Symptoms in a Phase 3 Randomized Clinical Trial in
Patients With Narcolepsy,” can be accessed at
https://academic.oup.com/sleep/advance-article/doi/10.1093/sleep/zsab200/6343406?searchresult=1.
“The publication of the REST-ON trial results in the
peer-reviewed journal SLEEP validates the potential of FT218 as a
once-at-bedtime option that could, if approved, transform the
treatment landscape for adults suffering from the burdensome
symptoms of narcolepsy,” said Jennifer Gudeman, Pharm.D., Vice
President of Medical and Clinical Affairs at Avadel. “We believe
FT218 has tremendous potential to provide clinically meaningful
results for people with narcolepsy. As we approach our October
PDUFA date, we remain confident in the potential of FT218 and are
committed to making FT218 accessible to patients, if approved.”
Topline data from the completed randomized, double-blind,
placebo-controlled REST-ON trial were announced in April 2020. The
study was designed to investigate the efficacy and safety of
once-at-bedtime FT218 for the treatment of EDS and cataplexy in
patients with narcolepsy. 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.
About FT218FT218 is an investigational,
once-nightly formulation of sodium oxybate that includes Avadel’s
proprietary, drug delivery 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 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 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
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 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.
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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Avadel Pharmaceuticals (NASDAQ:AVDL)
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