Avadel Pharmaceuticals plc (Nasdaq: AVDL), a biopharmaceutical
company focused on transforming medicines to transform lives,
announced today that it has submitted an amendment to the U.S. Food
and Drug Administration (“FDA”) requesting final approval for
LUMRYZ for the treatment of cataplexy or excessive daytime
sleepiness (EDS) in adults with narcolepsy. This submission follows
a unanimous 3-0 panel decision by the United States Court of
Appeals for the Federal Court (“Fed Circuit”) on February 24,
affirming the previous ruling from the United States District Court
for the District of Delaware (the “Delaware Court”), ordering Jazz
Pharmaceuticals (“Jazz”) to delist its U.S. Patent No. 8,731,963
(“REMS Patent”) from FDA’s Orange Book. Jazz submitted its request
to delist the REMS Patent to FDA on February 28.
“Today is an important day as we’ve taken what we believe is the
last step in the NDA review process with the submission of our
amendment to the LUMRYZ NDA seeking final approval. We look forward
to working with FDA to bring LUMRYZ to all eligible patients as
soon as possible,” said Greg Divis, Chief Executive Offer at Avadel
Pharmaceuticals. “The value proposition of LUMRYZ, demonstrated by
its important benefit to people living with narcolepsy, has been
our driving motivation throughout this process, and we stand ready
to bring LUMRYZ to the narcolepsy community following an
approval.”
Based on extensive patient and physician research, Avadel
estimates the total potential patient population for
once-at-bedtime LUMRYZ could be greater than 30,000, and expects
LUMRYZ, if approved, to be the treatment of choice for patients
suffering from narcolepsy-related EDS or cataplexy. The current
twice-nightly oxybate market for narcolepsy in the U.S. is
estimated at $1.8 billion comprised of approximately 16,000
patients. In addition, Avadel estimates that in the last three
years, 10,000 – 15,000 patients have discontinued their
twice-nightly oxybate use, many due to complications associated
with middle-of-the-night dosing. Furthermore, based on an analysis
of U.S. claims data, the Company believes that each year
approximately 3,000 patients initiate oxybate treatment for the
first time and expects this number to grow by 25-50% over time with
the introduction of LUMRYZ. Based on the estimated total potential
patient population, the market opportunity could be in excess of
$3.0 billion annually.
On July 18, 2022, LUMRYZ received tentative approval from the
FDA. On November 18, 2022, ruling on Avadel’s previously filed
motion, the Delaware Court issued its written opinion ordering Jazz
to request delisting of the REMS Patent. On February 24, 2023, the
Fed Circuit affirmed the Delaware Court’s order. Following Jazz’
request to delist the REMS Patent on February 28, 2023, Avadel
filed a minor amendment with the FDA on March 1, 2023, removing its
certification to the REMS Patent and requesting final approval of
LUMRYZ.
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.
On July 18, 2022, the FDA tentatively approved the LUMRYZ NDA
for the treatment of cataplexy or EDS in adults with
narcolepsy.
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 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 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 potential therapeutic
benefit of LUMRYZ; the outcome and timing of FDA’s final decision
regarding approval for LUMRYZ; ongoing efforts of the Company to
accelerate potential final FDA approval of LUMRYZ; the Company’s
efforts to make LUMRYZ commercially available (if approved);
expectations regarding the potential market opportunity and market
impact of LUMRYZ (if approved); and the anticipated 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)
과거 데이터 주식 차트
부터 6월(6) 2024 으로 7월(7) 2024
Avadel Pharmaceuticals (NASDAQ:AVDL)
과거 데이터 주식 차트
부터 7월(7) 2023 으로 7월(7) 2024