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UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 20549
FORM 8-K
CURRENT REPORT
Pursuant
to Section 13 or Section 15(d)
of the Securities Exchange Act of 1934
Date of Report
(Date of earliest event reported): July 31, 2024
AVADEL PHARMACEUTICALS PLC
(Exact name of registrant as specified
in its charter)
Ireland |
001-37977 |
98-1341933 |
(State or other jurisdiction |
(Commission |
(IRS Employer |
of incorporation) |
File Number) |
Identification No.) |
10
Earlsfort Terrace
Dublin 2, Ireland, D02
T380 |
Not Applicable |
(Address of principal executive offices) |
(Zip Code) |
Registrant’s telephone number, including
area code: +353
1 901 5201
Not Applicable
(Former name or former address,
if changed since last report)
Check the appropriate box below if the Form 8-K filing is intended
to simultaneously satisfy the filing obligation to the registrant under any of the following provisions:
¨ |
Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425) |
¨ |
Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12) |
¨ |
Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b)) |
¨ |
Pre-commencement communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13e-4(c)) |
Securities registered pursuant to Section
12(b) of the Act:
Title of each class |
Trading Symbol(s) |
Name of each exchange on which
registered |
Ordinary
Shares, nominal value $0.01 per share |
AVDL |
The Nasdaq Global Market |
Indicate by check mark whether the registrant is an emerging
growth company as defined in Rule 405 of the Securities Act of 1933 (§230.405 of this chapter) or Rule 12b-2 of the Securities
Exchange Act of 1934 (§240.12b-2 of this chapter).
Emerging growth company ¨
If an emerging growth company, indicate by check mark if the
registrant has elected not to use the extended transition period for complying with any new or revised financial accounting standards
provided pursuant to Section 13(a) of the Exchange Act. ¨
Item 7.01 |
Regulation FD Disclosure. |
On July 31, 2024, Avadel Pharmaceuticals plc (the “Company”)
issued a press release titled “Avadel Pharmaceuticals Announces First Patient Dosed in Phase 3 REVITALYZ™ Trial of LUMRYZ™
(sodium oxybate) Extended-Release Oral Suspension for the Treatment of Idiopathic Hypersomnia.” A copy of the press release is furnished
as Exhibit 99.1 to this Current Report on Form 8-K.
The information under this Item 7.01, including Exhibit 99.1 hereto,
is being furnished herewith and shall not be deemed “filed” for the purposes of Section 18 of the Securities Exchange
Act of 1934, as amended (the “Exchange Act”), or otherwise subject to the liabilities of that section, nor shall such information
be deemed incorporated by reference into any filing under the Securities Act of 1933, as amended, or the Exchange Act, except as expressly
set forth by specific reference in such filing.
On July 31, 2024, the Company announced
that the Company’s first patient has been dosed in REVITALYZ, a Phase 3 study evaluating LUMRYZ as a potential treatment for idiopathic
hypersomnia (“IH”). REVITALYZ is a double-blind, placebo-controlled, randomized withdrawal, multicenter Phase 3 study designed
to evaluate the efficacy and safety of LUMRYZ given as a once-at-bedtime dose, in IH.
Item 9.01 Exhibits.
(d) Exhibits
SIGNATURES
Pursuant to the requirements of the Securities
Exchange Act of 1934, the registrant has caused this report to be signed on its behalf by the undersigned hereunto duly authorized.
Date: July 31, 2024 |
AVADEL PHARMACEUTICALS PLC |
|
|
|
|
By: |
/s/ Jerad G. Seurer |
|
|
Name: |
Jerad G. Seurer |
|
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Title: |
General Counsel & Corporate Secretary |
Exhibit 99.1
Avadel Pharmaceuticals
Announces First Patient Dosed in Phase 3 REVITALYZ™ Trial of LUMRYZTM (sodium oxybate) Extended-Release Oral Suspension
for the Treatment of Idiopathic Hypersomnia
DUBLIN, Ireland, July 31, 2024
- Avadel Pharmaceuticals plc (Nasdaq: AVDL), a biopharmaceutical company focused on transforming medicines to transform lives, announced
today that the first patient has been dosed in REVITALYZ, a Phase 3 study evaluating LUMRYZ as a potential treatment for idiopathic hypersomnia
(IH).
"IH is a debilitating sleep disorder
characterized by profound sleep inertia, or difficulty waking up and persistent profound daytime sleepiness. Awareness and diagnosis
of IH has increased markedly over the last several years. However, IH patients are severely limited in effective treatment options,
representing a large unmet need,” said Richard K. Bogan, MD, FCCP, FAASM, Principal of Bogan Sleep Consultants, LLC, and Associate
Clinical Professor at University of South Carolina School of Medicine. "The potential of LUMRYZ to treat IH with only a single
bedtime dose of extended-release sodium oxybate is promising, and the initiation of the Phase 3 REVITALYZ study marks a significant step
toward improving care for those living with IH.”
REVITALYZ
is a double-blind, placebo-controlled, randomized withdrawal, multicenter Phase 3 study designed to evaluate the efficacy and
safety of LUMRYZ given as a once-at-bedtime dose, in IH. The study will enroll approximately 150 adults who are diagnosed with IH and
includes an open label extension portion. REVITALYZ enrollment is open for both participants switching from immediate-release oxybates
and not currently taking oxybates.
The primary objective of REVITALYZ is to
demonstrate reduction in daytime sleepiness as measured by the primary endpoint, change in total score of the Epworth Sleepiness Scale
(ESS) at Week 14. Secondary endpoints will evaluate the effect of LUMRYZ on additional efficacy parameters including patient and clinician
impression of change, idiopathic hypersomnia severity, and a measure of the functional outcomes of sleep.
“Dosing the first patient in REVITALYZ
is an important milestone for the IH community, which has been vocal in the need for more treatment options, particularly an extended-release
form of oxybate that would ideally provide full nocturnal drug exposure in a single, once-at-bedtime dose,” stated Jennifer Gudeman,
PharmD, Senior Vice President, Medical and Clinical Affairs of Avadel Pharmaceuticals. “We are committed to advancing this study
and are emboldened by the excitement of experienced clinical trial sites’ participation, which reflects the critical unmet need
in the current therapeutic landscape.”
Additional
information about the trial can be found at: https://clinicaltrials.gov (ClinicalTrials.gov
Identifier: NCT06525077).
About LUMRYZ™ (sodium oxybate)
for extended-release oral suspension
LUMRYZ is an extended-release sodium oxybate
medication approved by the FDA on May 1, 2023, as the first and only once-at-bedtime treatment for cataplexy or excessive daytime
sleepiness (EDS) in adults with narcolepsy.
The FDA approval of LUMRYZ was supported by results from REST-ON, a randomized, double-blind, placebo-controlled, pivotal Phase 3 trial
in adults with narcolepsy. LUMRYZ demonstrated statistically significant and clinically meaningful improvements in the three co-primary
endpoints: EDS, clinicians’ overall assessment of patients’ functioning (CGI-I), and cataplexy attacks, for all three evaluated
doses when compared to placebo.
With its approval, the FDA also granted seven years of Orphan Drug Exclusivity to LUMRYZ for the treatment of cataplexy or EDS in adults
with narcolepsy due to a finding of clinical superiority of LUMRYZ relative to currently available oxybate treatments. In particular,
the FDA found that LUMRYZ makes a major contribution to patient care over currently available, twice-nightly oxybate products by providing
a once-nightly dosing regimen that avoids nocturnal arousal to take a second dose.
About Idiopathic Hypersomnia
Idiopathic hypersomnia (IH) is a rare sleep
disorder characterized by excessive daytime sleepiness (EDS) not attributable to any other medical conditions or symptom of another medical
condition. Symptoms may include prolonged nocturnal sleep of good quality, difficulty in waking up, and brain fog. Additional symptoms
may include falling asleep unintentionally, challenges in maintaining focus, and occasional memory lapses. IH can have a significant
impact on a patient’s quality of life. According to claims data, there are an estimated 37,000 diagnosed IH patients in the United
States, although the total patient population may be greater due to some patients who have not yet been diagnosed, have been misdiagnosed,
or are not currently seeking treatment.
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. Avadel’s commercial product, LUMRYZ, was approved by the U.S. Food & Drug Administration (FDA) as the
first and only once-at-bedtime oxybate for the treatment of cataplexy or excessive daytime sleepiness (EDS) in adults with narcolepsy.
For more information, please visit www.avadel.com.
IMPORTANT SAFETY INFORMATION
WARNING: Taking LUMRYZ™ (sodium oxybate) with other central
nervous system (CNS) depressants, such as medicines used to make you fall asleep, including opioid analgesics, benzodiazepines, sedating
antidepressants, antipsychotics, sedating anti-epileptic medicines, general anesthetics, muscle relaxants, alcohol or street drugs,
may cause serious medical problems, including trouble breathing (respiratory depression), low blood pressure (hypotension), changes
in alertness (drowsiness), fainting (syncope) and death.
The active ingredient of LUMRYZ (sodium oxybate) is a form
of gamma hydroxybutyrate (GHB), a controlled substance. Abuse or misuse of illegal GHB alone or with other CNS depressants (drugs
that cause changes in alertness or consciousness) have caused serious side effects. These effects include seizures, trouble breathing
(respiratory depression), changes in alertness (drowsiness), coma and death. Call your doctor right away if you have any of these
serious side effects.
Because of these risks, LUMRYZ is available only by prescription
and filled through certified pharmacies in the LUMRYZ REMS. You must be enrolled in the LUMRYZ REMS to receive LUMRYZ. Further information
is available at www.LUMRYZREMS.com or by calling 1-877-453-1029. |
INDICATIONS
LUMRYZ (sodium oxybate) for extended-release oral suspension is a prescription medicine used to treat the
following symptoms in adults with narcolepsy:
| · | sudden
onset of weak or paralyzed muscles (cataplexy) |
| · | excessive
daytime sleepiness (EDS) |
It is not known if LUMRYZ is safe and effective in people less than
18 years of age.
Do
not take LUMRYZ if you take other sleep medicines or sedatives (medicines that cause sleepiness), drink alcohol or have
a rare problem called succinic semialdehyde dehydrogenase deficiency.
Keep LUMRYZ in a safe place to prevent abuse and misuse. Selling or
giving away LUMRYZ may harm others and is against the law. Tell your doctor if you have ever abused or been dependent on alcohol, prescription
medicines or street drugs.
Anyone who takes LUMRYZ should not do anything that requires them
to be fully awake or is dangerous, including driving a car, using heavy machinery or flying an airplane, for at least six (6) hours
after taking LUMRYZ. Those activities should not be done until you know how LUMRYZ affects you.
Falling asleep quickly, including while standing or while getting
up from the bed, has led to falls with injuries that have required some people to be hospitalized.
LUMRYZ can cause serious side effects, including the following:
| · | Breathing
problems, including slower breathing, trouble breathing and/or short periods of
not breathing while sleeping (e.g., sleep apnea). People who already have breathing or lung
problems have a higher chance of having breathing problems when they take LUMRYZ. |
| · | Mental
health problems, including confusion, seeing or hearing things that are not real
(hallucinations), unusual or disturbing thoughts (abnormal thinking), feeling anxious or
upset, depression, thoughts of killing yourself or trying to kill yourself, increased tiredness,
feelings of guilt or worthlessness and difficulty concentrating. Tell your doctor if you
have or had depression or have tried to harm yourself. Call your doctor right away
if you have symptoms of mental health problems or a change in weight or appetite. |
| · | Sleepwalking. Sleepwalking
can cause injuries. Call your doctor if you start sleepwalking. |
Tell your doctor if you are on a salt-restricted diet or if you have
high blood pressure, heart failure or kidney problems. LUMRYZ contains a lot of sodium (salt) and may not be right for you.
The most common side effects of LUMRYZ in adults include nausea, dizziness,
bedwetting, headache and vomiting. Your side effects may increase when you take higher doses of LUMRYZ. LUMRYZ can cause physical dependence
and craving for the medicine when it is not taken as directed. These are not all the possible side effects of LUMRYZ.
For more information, ask your doctor or pharmacist. Call your
doctor for medical advice about side effects.
You are encouraged to report negative side effects of prescription
drugs to the FDA. Visit www.fda.gov/medwatch, or call 1-800-FDA-1088.
Please see full Prescribing Information, including BOXED Warning.
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 and market preference for LUMRYZ in idiopathic hypersomnia, if approved; the progress, timing and
success of the Phase 3 REVITALYZ trial, including expectations for trial design and enrollment; and statements regarding the results
and analysis of Avadel’s trials and studies including the details and content thereof. 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, 2023, which was filed with the Securities
and Exchange Commission (SEC) on February 29, 2024, 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 Mogerley
Precision AQ
Courtney.Mogerley@precisionaq.com
(212) 698-8687
Media Contact:
Lesley Stanley
Real Chemistry
lestanley@realchemistry.com
(609) 273-3162
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