Avadel Pharmaceuticals plc (Nasdaq: AVDL), a biopharmaceutical
company focused on transforming medicines to transform lives, today
announced that the U.S. Food and Drug Administration (“FDA”) has
approved its Pre-Launch Activities Importation Requests (PLAIR) for
LUMRYZ.
Through its PLAIR, Avadel is authorized to import unapproved
drug product into the U.S. ahead of anticipated final approval of
the tentatively approved LUMRYZ NDA, to prepare for market launch.
By importing LUMRYZ into the U.S. before anticipated final
approval, Avadel is able to further shorten the time to product
availability following a final approval decision by the FDA.
“The granting of our PLAIR request by the FDA followed the
submission of our amendment requesting a final approval decision
for LUMRYZ. The approval to import LUMRYZ comes at an important
time for Avadel as the availability of commercial supply allows us
to further shorten the timeline between a potential approval and
being able to provide LUMRYZ to patients,” said Greg Divis, Chief
Executive Officer of Avadel Pharmaceuticals. “We remain committed
to working collaboratively with FDA to bring LUMRYZ to people
living with narcolepsy.”
About LUMRYZ
LUMRYZ 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
excessive daytime sleepiness (EDS) 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 LUMRYZ in patients with narcolepsy.
Among the three co-primary endpoints, LUMRYZ 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 U.S. Food and Drug Administration (FDA)
granted LUMRYZ Orphan Drug Designation for the treatment of
narcolepsy based on the plausible hypothesis that LUMRYZ may be
safer than the twice-nightly formulation of sodium oxybate already
approved by the FDA due to the ramifications associated with the
dosing regimen of that product. LUMRYZ is currently under review by
the FDA.
On July 18, 2022, the FDA tentatively approved the LUMRYZ NDA
for the treatment of cataplexy or EDS in adults with narcolepsy.
Avadel submitted a minor amendment to the FDA on March 1, 2023,
requesting final approval of LUMRYZ. This minor amendment
submission occurred shortly after the delisting of the REMS Patent
from FDA’s Orange Book by Jazz Pharmaceuticals in response to the
unanimous 3-0 panel decision by the United States Court of Appeals
for the Federal Circuit on February 24, affirming the previous
ruling from the United States District Court for the Federal
District of Delaware, ordering Jazz to do so.
Avadel is currently evaluating the long-term safety and
tolerability of LUMRYZ in the open-label RESTORE clinical study.
For more information, visit: www.restore-narcolepsy-study.com.
About PLAIR
A PLAIR allows for applicants with a pending NDA, ANDA, or
CDER-regulated BLA nearing an FDA application decision to request
permission to import an unapproved finished dosage form drug
product for reconditioning in the form of approval. FDA’s granting
of a PLAIR does not represent an implicit or explicit statement of
the approvability of the NDA, ANDA, or CDER-regulated BLA. Rather,
PLAIR facilitates the process for importing unapproved finished
dosage form products to prepare for market launch based on
anticipated approval of the pending application.
About Avadel Pharmaceuticals plc
Avadel 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, LUMRYZ,
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
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,
expectations regarding the FDA’s potential final approval of
LUMRYZ, including the timing of thereof; the anticipated time
savings between a potential approval and commercial launch of
LUMRYZ attributable to the FDA’s grant of the PLAIR; the Company’s
preparation for launch of LUMRYZ (if approved); and the market
acceptance of LUMRYZ (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 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
Avadel Pharmaceuticals (NASDAQ:AVDL)
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Avadel Pharmaceuticals (NASDAQ:AVDL)
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