# EDGAR Filing Document

**Accession Number:** 0001012477
**File Stem:** 0001104659-25-056674
**Filing Date:** 2025-6
**Character Count:** 19137
**Document Hash:** 4093ae87e9dfb015c738fe96273940ea
**Contains OCR:** False
**Source Format:** 

## Filing Content

## Filing Summary
**0001104659-25-056674.hdr.sgml**: 20250605

**ACCESSION NUMBER**: 0001104659-25-056674

**CONFORMED SUBMISSION TYPE**: 8-K

**PUBLIC DOCUMENT COUNT**: 14

**CONFORMED PERIOD OF REPORT**: 20250605

**ITEM INFORMATION**: Regulation FD Disclosure

**ITEM INFORMATION**: Other Events

**ITEM INFORMATION**: Financial Statements and Exhibits

**FILED AS OF DATE**: 20250605

**DATE AS OF CHANGE**: 20250605

**FILER**: 

**COMPANY DATA:**
- **COMPANY CONFORMED NAME:** AVADEL PHARMACEUTICALS PLC
- **CENTRAL INDEX KEY:** 0001012477
- **STANDARD INDUSTRIAL CLASSIFICATION:** PHARMACEUTICAL PREPARATIONS [2834]
- **ORGANIZATION NAME:** 03 Life Sciences
- **EIN:** 000000000
- **FISCAL YEAR END:** 1231

**FILING VALUES:**
- **FORM TYPE:** 8-K
- **SEC ACT:** 1934 Act
- **SEC FILE NUMBER:** 001-37977
- **FILM NUMBER:** 251025026

**BUSINESS ADDRESS:**
- **STREET 1:** BLOCK 10-1 BLANCHARDSTOWN CORPORATE PARK
- **STREET 2:** BALLYCOOLIN
- **CITY:** DUBLIN
- **STATE:** L2
- **ZIP:** 15
- **BUSINESS PHONE:** 636-449-1830

**MAIL ADDRESS:**
- **STREET 1:** 16640 CHESTERFIELD GROVE ROAD
- **STREET 2:** SUITE 200
- **CITY:** CHESTERFIELD
- **STATE:** MO
- **ZIP:** 63005

**FORMER COMPANY:**
- **FORMER CONFORMED NAME:** FLAMEL TECHNOLOGIES SA
- **DATE OF NAME CHANGE:** 19960422

?xml version='1.0' encoding='ASCII'?

**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)**: June 5, 2025

**AVADEL PHARMACEUTICALS PLC**

**(Exact name of registrant as specified in its charter)**

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| | | |
|:---|:---|:---|
| &nbsp;&nbsp;**Ireland** | &nbsp;&nbsp;**001-37977** | &nbsp;&nbsp;**98-1341933** |
| &nbsp;&nbsp;(State or other jurisdiction | &nbsp;&nbsp;(Commission | &nbsp;&nbsp;(IRS Employer |
| &nbsp;&nbsp;of incorporation) | &nbsp;&nbsp;File Number) | &nbsp;&nbsp;Identification No.) |

---

---

| | |
|:---|:---|
| &nbsp;&nbsp;**10 Earlsfort Terrace**<br> **Dublin 2**, **Ireland, D02 T380** | &nbsp;&nbsp;<br> **Not Applicable** |
| &nbsp;&nbsp;(Address of principal executive offices) | &nbsp;&nbsp;(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:

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| | | |
|:---|:---|:---|
| Title of each class | Trading Symbol(s) | Name of each exchange on which <br> 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. ◻

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| | |
|:---|:---|
| **Item 7.01** | **Regulation FD Disclosure.** |

---

On June 5, 2025, Avadel Pharmaceuticals plc (the "Company") issued a press release announcing that the U.S. Food and Drug Administration (the "FDA") granted Orphan Drug Designation to LUMRYZ<sup>TM</sup> 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.*

---

| | |
|:---|:---|
| **Item 8.01** | **Other Events.** |

---

On June 5, 2025, the Company announced that the FDA granted Orphan Drug Designation to LUMRYZ for the treatment of idiopathic hypersomnia.

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| | |
|:---|:---|
| **Item 9.01** | **Exhibits.** |

---

(d) Exhibits

[99.1](tm2517242d1_ex99-1.htm) [Press release issued by Avadel Pharmaceuticals plc on June 5, 2025, furnished herewith.](tm2517242d1_ex99-1.htm) <br> 104 Cover Page Interactive Data File (embedded with the Inline XBRL document).

**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: June 5, 2025 | **AVADEL PHARMACEUTICALS PLC** | **AVADEL PHARMACEUTICALS PLC** | **AVADEL PHARMACEUTICALS PLC** |
|  | By: | /s/ Jerad G. Seurer | /s/ Jerad G. Seurer |
|  |  | Name: | Jerad G. Seurer |
|  |  | Title: | General Counsel & Corporate Secretary |

---

## Exhibit 99.1

**Exhibit 99.1**

![](tm2517242d1_ex99-1img001.jpg)

**Avadel Pharmaceuticals Receives Orphan Drug Designation from FDA for LUMRYZ<sup>TM</sup> (sodium oxybate) for Extended-Release Oral Suspension for the Treatment of Idiopathic Hypersomnia** 

DUBLIN, Ireland, June 5, 2025 - Avadel Pharmaceuticals plc (Nasdaq: AVDL), a biopharmaceutical company focused on transforming medicines to transform lives, announced today that LUMRYZ<sup>TM</sup> has been granted Orphan Drug Designation (ODD) from the U.S. Food & Drug Administration (FDA) for the treatment of Idiopathic Hypersomnia (IH). Specifically, ODD was granted based on the plausible hypothesis that LUMRYZ may be clinically superior to the same drug(s) already approved for the same indication, because LUMRYZ may provide a major contribution to patient care due to its once-nightly dosing for patients with IH, a chronic sleep disorder that requires potentially lifelong treatment.

"We are pleased that LUMRYZ has been granted Orphan Drug Designation for the treatment of IH, and this recognition reinforces our strategy to develop differentiated therapies for patients with rare sleep disorders," said Greg Divis, Chief Executive Officer of Avadel Pharmaceuticals. "Receipt of ODD highlights the unique value of our next-generation, extended-release oxybate and its potential for IH patients, if approved. We continually hear from clinicians and patients of the substantial need for an extended-release oxybate for this patient population – a population who suffers from profound sleep inertia, making waking up in the middle of the night an even greater challenge than in narcolepsy. With continued progress in our pivotal Phase 3 REVITALYZ trial, an established commercial foundation in narcolepsy, and a relentlessly devoted team, we are well-positioned to advance LUMRYZ in IH with the goal of ultimately transforming the IH treatment landscape, if approved."

IH is a rare and debilitating sleep disorder characterized by excessive daytime sleepiness not attributable to any other medical conditions. LUMRYZ is currently being evaluated for the treatment of IH in the REVITALYZ™ trial, which is a double-blind, placebo-controlled, randomized withdrawal, multicenter Phase 3 study designed to evaluate the efficacy and safety of LUMRYZ when given as a once-at-bedtime dose. The study will enroll approximately 150 adults who are diagnosed with IH. REVITALYZ enrollment is open for both participants switching from immediate-release oxybates as well as those not currently taking oxybates, and is on track to be completed by year end 2025.

Orphan Drug Designation is granted by the FDA to support drug development for rare diseases and is assigned to drugs and biologics that demonstrate promise for the diagnosis and/or treatment of rare diseases or conditions that affect fewer than 200,000 people in the U.S. The designation can provide several benefits for the development and commercialization of indicated compounds and medicines which include eligibility for a seven-year period of market exclusivity in the U.S. following product approval, FDA assistance in clinical trial design and an exemption from FDA user fees.

**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

![](tm2517242d1_ex99-1img001.jpg)

sleepiness (EDS) in adults with narcolepsy. On October 16, 2024, LUMRYZ was additionally approved as a once-at-bedtime treatment for cataplexy or EDS in pediatric patients 7 years of age and older 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 (MWT), clinicians' overall assessment of patients' functioning (CGI-I), and cataplexy attacks, for all three evaluated doses when compared to placebo.

With its approvals in May 2023 and October 2024, the FDA also granted 7 years of Orphan Drug Exclusivity to LUMRYZ for the treatment of cataplexy or EDS in adults with narcolepsy and in pediatric patients 7 years of age and older with narcolepsy (respectively) 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.

LUMRYZ is only currently approved for the treatment of cataplexy or EDS in patients 7 years of age and older with narcolepsy, and Avadel does not sell LUMRYZ for any indication beyond narcolepsy.

**INDICATIONS**<br> LUMRYZ (sodium oxybate) for extended-release oral suspension is a prescription medicine used to treat the following symptoms in patients 7 years of age and older with narcolepsy:

&nbsp;&nbsp;&nbsp;&nbsp;· sudden onset of weak or paralyzed muscles (cataplexy)

&nbsp;&nbsp;&nbsp;&nbsp;· excessive daytime sleepiness (EDS)

**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**

![](tm2517242d1_ex99-1img001.jpg)

**to receive LUMRYZ. Further information is available at www.LUMRYZREMS.com or by calling 1-877-453-1029.**

**Do not take LUMRYZ if you take or your child takes** 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 or your child 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:**

&nbsp;&nbsp;&nbsp;&nbsp;· **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.

&nbsp;&nbsp;&nbsp;&nbsp;· **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 or your child have or had depression or have tried to harm yourself. **Call your doctor right away if you or your child have symptoms of mental health problems or a change in weight or appetite.** 

&nbsp;&nbsp;&nbsp;&nbsp;· **Sleepwalking.** Sleepwalking can cause injuries. Call your doctor if
you or your child start sleepwalking.

Tell your doctor if you or your child are on a salt-restricted diet or 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. The most common side effects in children include nausea, bedwetting, vomiting, headache, decreased weight, decreased appetite, dizziness, and sleepwalking.

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.

![](tm2517242d1_ex99-1img001.jpg)

**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, and Medication Guide.**

**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 EDS in patients 7 years of age and older with narcolepsy. For more information, please visit **www.avadel.com**.

Avadel intends to use its Investor Relations website as a means of disclosing material nonpublic information and for complying with its disclosure obligations under Regulation FD. Accordingly, investors should monitor the Company's Investor Relations website, in addition to following the Company's press releases, SEC filings, public conference calls, presentations, and webcast.

**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 Company's strategy to develop differentiated therapies for patients with rare sleep disorders, including IH; expectations regarding LUMRYZ's ability to transform the IH treatment landscape; expectations regarding potential FDA approval and subsequent commercialization of LUMRYZ for the treatment of IH; the potential benefits of orphan drug designation; and the progress, timing and success of the REVITALYZ trial, including expectations for enrollment. In some cases, forward-looking statements can be identified by 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 most recent Annual Report on Form 10-K and subsequent filings with the Securities and Exchange Commission.

![](tm2517242d1_ex99-1img001.jpg)

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:**

Austin Murtagh<br> Precision AQ<br> Austin.Murtagh@precisionaq.com<br> (212) 698-8696

**Media Contact:**

Lesley Stanley

Real Chemistry

lestanley@realchemistry.com

(609) 273-3162