Avadel Pharmaceuticals Announces Ongoing FDA Review of NDA for FT218 for Patients with Narcolepsy
October 15 2021 - 5:00PM
Avadel Pharmaceuticals plc (Nasdaq: AVDL), a company focused on
transforming medicines to transform lives, announced today that the
U.S. Food and Drug Administration (FDA) notified the company that
the review of the New Drug Application (NDA) for FT218 is still
ongoing, and action will likely not be taken in October. The FDA
informed the company that there are no information requests at this
time and a new target action date will be provided as soon as
possible.
“We have addressed all questions received to date and remain
confident that the package we have submitted satisfies all of the
FDA’s requests. We have not been informed of any deficiencies in
our application and remain fully committed to work closely with the
FDA for the duration of its review of our NDA for FT218,” said Greg
Divis, Chief Executive Officer of Avadel. “Once-at-bedtime FT218
has the potential to truly impact the way people with narcolepsy
are able to live their lives and we are dedicated to making this
important therapy available to patients as quickly as
possible.”
In February 2021, the FDA accepted Avadel’s NDA for FT218 and
assigned a target action date of October 15, 2021. The NDA
submission is supported by positive data from the pivotal Phase 3
REST-ON study, which was completed under a Special Protocol
Assessment (SPA) agreement with the FDA.
About FT218FT218 is an investigational
formulation of sodium oxybate leveraging Avadel’s 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 patients 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 doses when
compared to placebo.
In January 2018, the 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 or
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 timing of the FDA’s review of the NDA
for FT218 and the sufficiency of data supporting the NDA for FT218.
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, 2020 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
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