Avadel Pharmaceuticals (AVDL) FDA Approvals

Avadel Pharmaceuticals' Drug in the FDA Approval Process

This section highlights FDA-related milestones and regulatory updates for drugs developed by Avadel Pharmaceuticals (AVDL). Over the past two years, Avadel Pharmaceuticals has reported clinical trial outcomes, regulatory submissions, approvals, and other FDA events for drugs and therapies such as LUMRYZ. For definitions of regulatory abbreviations such as NDA, BLA, or PDUFA, see the event status legend.

LUMRYZ (sodium oxybate) FDA Regulatory Timeline and Events

LUMRYZ (sodium oxybate) is a drug developed by Avadel Pharmaceuticals for the following indication: Extended-release sodium oxybate medication. This drug is under review by the U.S. Food and Drug Administration (FDA). Below is a timeline of key regulatory milestones for this therapy.

Enrollment Update - December 18,2025

Phase 3

• Drug: LUMRYZ (sodium oxybate)
• Announced Date: December 18, 2025
• Indication: Extended-release sodium oxybate medication

Avadel Pharmaceuticals plc announced the completion of patient enrollment in REVITALYZ, a Phase 3 trial evaluating LUMRYZTM (sodium oxybate) extended-release oral suspension as a potential treatment for idiopathic hypersomnia (IH).

Avadel Pharmaceuticals announced it has finished enrolling patients in REVITALYZ, a Phase 3 study testing LUMRYZ (extended‑release sodium oxybate) as a possible treatment for idiopathic hypersomnia (IH). The company expects top‑line data in Q2 2026. REVITALYZ is a multicenter, double‑blind, placebo‑controlled, randomized‑withdrawal trial designed to assess a once‑at‑bedtime dose of LUMRYZ.

The trial includes people switching from immediate‑release oxybates and those not currently taking oxybates. The primary goal is to show a reduction in daytime sleepiness measured by the change in total score on the Epworth Sleepiness Scale (ESS) at Week 14. Secondary measures will look at patient and clinician impressions of change, IH severity, and functional outcomes of sleep.

Avadel said completing enrollment is an important step for the IH community and thanked patients and investigators who joined the study. More details are available at ClinicalTrials.gov (Identifier: NCT06525077).

Data - September 5,2025

• Drug: LUMRYZ (sodium oxybate)
• Announced Date: September 5, 2025
• Indication: Extended-release sodium oxybate medication

Avadel Pharmaceuticals plc announced that new data supporting the use of LUMRYZ as a narcolepsy treatment will be presented in one oral presentation and 16 posters at World Sleep 2025, taking place September 5-10, in Singapore.

Regulatory Update - June 30,2025

• Drug: LUMRYZ (sodium oxybate)
• Announced Date: June 30, 2025
• Indication: Extended-release sodium oxybate medication

Avadel Pharmaceuticals plc announced that, on Friday, June 27, 2025, the U.S. Court of Appeals for the District of Columbia Circuit (the "Appeals Court") affirmed a prior decision of the U.S. District Court for the District of Columbia (the "District Court") in favor of the U.S. Food and Drug Administration ("FDA") in a suit brought by Jazz Pharmaceuticals Inc.

Avadel Pharmaceuticals announced that on June 27, 2025, the U.S. Court of Appeals for the District of Columbia Circuit upheld a previous District Court ruling in favor of the FDA. This decision resolves a lawsuit brought by Jazz Pharmaceuticals regarding the FDA’s approval of LUMRYZ™, the first and only once-at-bedtime oxybate treatment for narcolepsy patients aged 7 and older.

The ruling confirms that the FDA’s approval of LUMRYZ, which offers significant improvements over older, immediate-release oxybate medications, is well-founded. The court noted that the FDA’s decision was undisputed and reinforced LUMRYZ’s clinical benefits, including providing patients with a full therapeutic dose in one nightly administration. Avadel views this affirmation as a strong endorsement of the innovative dosing regimen and a critical step in enhancing treatment options for people with narcolepsy.

Designation Grant - June 5,2025

Orphan Drug

• Drug: LUMRYZ (sodium oxybate)
• Announced Date: June 5, 2025
• Indication: Extended-release sodium oxybate medication

Avadel Pharmaceuticals plc announced that LUMRYZTM has been granted Orphan Drug Designation (ODD) from the U.S. Food & Drug Administration (FDA) for the treatment of Idiopathic Hypersomnia (IH).

Avadel Pharmaceuticals announced that its product LUMRYZ has received Orphan Drug Designation (ODD) from the U.S. FDA for the treatment of Idiopathic Hypersomnia (IH), a rare sleep disorder characterized by excessive daytime sleepiness. The FDA granted ODD based on the potential for LUMRYZ to be clinically superior to existing treatments, largely due to its once-nightly dosing regimen that could improve patient care and simplify treatment routines.

CEO Greg Divis emphasized that this designation supports Avadel’s strategy to provide differentiated therapies for rare sleep disorders. The recognition also offers benefits such as market exclusivity and support in clinical trial design. Avadel is currently advancing the REVITALYZ Phase 3 trial for IH, working toward a future where LUMRYZ may transform the treatment landscape for patients suffering from this chronic condition.

New Data - May 29,2025

• Drug: LUMRYZ (sodium oxybate)
• Announced Date: May 29, 2025
• Indication: Extended-release sodium oxybate medication

Avadel Pharmaceuticals plc announced that new data supporting the use of LUMRYZ as a narcolepsy treatment and additional data to better understand the real-life experience of people living with narcolepsy will be presented in four oral presentations and 14 posters at SLEEP 2025, the 39th Annual Meeting of the Associated Professional Sleep Societies (APSS), taking place June 8-11, 2025 in Seattle.

Avadel Pharmaceuticals announced that new data supporting LUMRYZ as a narcolepsy treatment will be showcased at SLEEP 2025, the 39th Annual Meeting of the Associated Professional Sleep Societies, in Seattle from June 8-11, 2025. The data will include findings from clinical trials and real-world studies, reinforcing LUMRYZ’s benefits. One study highlighted that patients switching from twice-nightly oxybate to once-at-bedtime LUMRYZ showed significant improvements in excessive daytime sleepiness, with results indicating normalization of sleepiness levels. In addition, post-hoc analyses from key trials are expected to provide insights into safety and overall effectiveness, even among patients with severe sleepiness. The presentations include four oral sessions and 14 posters, offering healthcare professionals a broad spectrum of evidence on the benefits and tolerability of LUMRYZ in both clinical and practical settings.

Data Presentation - September 3,2024

• Drug: LUMRYZ (sodium oxybate)
• Announced Date: September 3, 2024
• Indication: Extended-release sodium oxybate medication

Avadel Pharmaceuticals announced the publication of final data from the RESTORE open-label/switch study, demonstrating that people with narcolepsy prefer once-at-bedtime LUMRYZ versus a twice-nightly immediate-release oxybate treatment option.

Avadel Pharmaceuticals has published the final data from the RESTORE open-label/switch study, which shows that people with narcolepsy prefer the once-at-bedtime dosing regimen of LUMRYZ over twice-nightly immediate-release oxybate treatments. In the study, 94% of participants favored the once-nightly option, reporting that it improved their sleep and reduced the inconvenience of waking up for a second dose. Additionally, 91% of those who switched to LUMRYZ said they were better able to sleep through the night, and 93% would recommend LUMRYZ to family or friends with narcolepsy. The RESTORE study highlighted concerns with twice-nightly dosing, such as grogginess and decreased symptom control when doses were missed, making LUMRYZ a more attractive and effective treatment option for managing narcolepsy symptoms.

Published Results - August 20,2024

Phase 3

• Drug: LUMRYZ (sodium oxybate)
• Announced Date: August 20, 2024
• Indication: Extended-release sodium oxybate medication

Avadel Pharmaceuticals announced the publication of results of a post-hoc analysis from the completed pivotal Phase 3 REST-ON clinical trial demonstrating greater weight loss in patients who received LUMRYZ compared with placebo.

Avadel Pharmaceuticals announced that a post-hoc analysis from its pivotal Phase 3 REST-ON trial shows patients receiving LUMRYZ experienced greater weight loss compared with placebo. The analysis, published in Clinical Therapeutics, highlighted that over a 13-week period, patients treated with LUMRYZ lost an average of 1.3 kg, while those on placebo actually gained about 0.2 kg. Furthermore, significantly more patients taking LUMRYZ (17.8%) achieved a weight loss of at least 5% compared to just 3.8% in the placebo group. The findings also revealed a notable reduction in body mass index, with some participants moving from obese to overweight and from overweight to normal weight. These results underline the potential of LUMRYZ not only for improving narcolepsy symptoms such as cataplexy and excessive daytime sleepiness, but also for addressing weight management in this patient population.

Dose Update - July 31,2024

Phase 3

• Drug: LUMRYZ (sodium oxybate)
• Announced Date: July 31, 2024
• Indication: Extended-release sodium oxybate medication

Avadel Pharmaceuticals plc , 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).

Avadel Pharmaceuticals plc announced a new milestone in its research with the dosing of the first patient in REVITALYZ, a Phase 3 study that is testing LUMRYZ as a potential treatment for idiopathic hypersomnia (IH). IH is a debilitating sleep disorder that causes severe daytime sleepiness and difficulty waking up. The study is designed to evaluate the effectiveness and safety of a single bedtime dose of extended-release sodium oxybate in approximately 150 adult patients. This trial is significant because there are limited treatment options for IH, and the once-at-bedtime dosing of LUMRYZ may offer a promising new approach. REVITALYZ is a double-blind, placebo-controlled trial, which will also include an open label extension portion to gather more data on the drug’s impact on daytime sleepiness and overall patient functioning.

Oral presentation - May 22,2024

• Drug: LUMRYZ (sodium oxybate)
• Announced Date: May 22, 2024
• Indication: Extended-release sodium oxybate medication

Avadel Pharmaceuticals announced today it will present 11 posters, and one oral presentation, supporting the use of LUMRYZ as a narcolepsy treatment option at SLEEP 2024, the 38th annual joint meeting of the American Academy of Sleep Medicine and the Sleep Research Society on June 1-5, 2024, in Houston.

Avadel Pharmaceuticals announced it will present 11 posters and one oral presentation at SLEEP 2024, the annual joint meeting of the American Academy of Sleep Medicine and the Sleep Research Society, scheduled for June 1-5, 2024, in Houston. These presentations will share new data supporting the continued use of LUMRYZ as a narcolepsy treatment option. The data, including findings from the RESTORE study, highlight high patient satisfaction and a clear preference for once-at-bedtime dosing compared to twice-nightly oxybate treatment. Researchers will discuss how LUMRYZ improves symptom control for cataplexy and excessive daytime sleepiness while helping patients sleep through the night. This initiative underlines Avadel’s commitment to addressing treatment gaps and improving care for adults with narcolepsy by offering a more convenient and effective therapeutic option.

Poster Presentation - May 22,2024

• Drug: LUMRYZ (sodium oxybate)
• Announced Date: May 22, 2024
• Indication: Extended-release sodium oxybate medication

Avadel Pharmaceuticals announced today it will present 11 posters, and one oral presentation, supporting the use of LUMRYZ as a narcolepsy treatment option at SLEEP 2024, the 38th annual joint meeting of the American Academy of Sleep Medicine and the Sleep Research Society on June 1-5, 2024, in Houston.

Avadel Pharmaceuticals announced it will present 11 posters and one oral presentation at SLEEP 2024, the 38th annual joint meeting of the American Academy of Sleep Medicine and the Sleep Research Society in Houston from June 1-5, 2024. The sessions will support the use of LUMRYZ as a narcolepsy treatment option, showcasing new data that highlights patient satisfaction, improved symptom control, and better adherence compared to twice-nightly dosing options. Included in the presentations are findings from the RESTORE study, which reveal high patient preference for once-at-bedtime dosing, improved nighttime sleep, and overall enhanced daytime performance. By sharing this research, Avadel is emphasizing its commitment to addressing gaps in narcolepsy care and providing healthcare professionals with valuable insights into optimizing treatment strategies for patients with narcolepsy.

PDUFA Date - May 8,2024

supplemental New Drug Application (sNDA)

• Drug: LUMRYZ (sodium oxybate)
• Announced Date: May 8, 2024
• Target Action Date: September 7, 2024
• Indication: Extended-release sodium oxybate medication

Avadel Pharmaceuticals plc announced that The FDA has assigned a target action date of September 7, 2024.

Avadel Pharmaceuticals announced that the U.S. Food and Drug Administration (FDA) has set a target action date of September 7, 2024, for reviewing its Supplemental New Drug Application (sNDA) for LUMRYZ in children with narcolepsy. This submission aims to expand the use of LUMRYZ, currently approved for adults with narcolepsy, to help treat cataplexy and excessive daytime sleepiness in the pediatric population. If approved, this could relieve some of the burdens on families and caregivers by reducing the need for disruptive nighttime dosing. Avadel plans to continue advancing its research and clinical trials as part of its ongoing commitment to improving treatments for sleep disorders. The company is focused on ensuring that both adult and pediatric patients have access to treatments that potentially offer a simpler dosing regimen and improved overall management of their condition.

FDA Accepted - May 8,2024

supplemental New Drug Application (sNDA)

• Drug: LUMRYZ (sodium oxybate)
• Announced Date: May 8, 2024
• Indication: Extended-release sodium oxybate medication

Avadel Pharmaceuticals plc announced that U.S. Food and Drug Administration (FDA) accepted the Supplemental New Drug Application (sNDA) for LUMRYZ for treatment of cataplexy or EDS in the pediatric narcolepsy population.

Avadel Pharmaceuticals has received a major boost as the FDA accepted the Supplemental New Drug Application (sNDA) for LUMRYZ, targeting cataplexy and excessive daytime sleepiness (EDS) in pediatric narcolepsy patients. The application, which focuses on expanding the drug’s use beyond adults, now awaits a decision from the FDA, with a target action date set for September 7, 2024.

If approved, LUMRYZ could offer a significant improvement for children with narcolepsy, a group that makes up about 5% of all oxybate-treated patients. The new indication may help reduce the nighttime burden on families and caregivers who currently face the challenge of administering a second dose, thereby offering a more convenient, once-at-bedtime treatment option and easing the overall management of the condition.

Avadel Pharmaceuticals FDA Events - Frequently Asked Questions

Has Avadel Pharmaceuticals received FDA approval?

As of now, Avadel Pharmaceuticals (AVDL) has not received any FDA approvals for its therapy in the last two years.

What drugs has Avadel Pharmaceuticals submitted to the FDA?

In the past two years, Avadel Pharmaceuticals (AVDL) has reported FDA regulatory activity for LUMRYZ (sodium oxybate).

What is the most recent FDA event for Avadel Pharmaceuticals?

The most recent FDA-related event for Avadel Pharmaceuticals occurred on December 18, 2025, involving LUMRYZ (sodium oxybate). The update was categorized as "Enrollment Update," with the company reporting: "Avadel Pharmaceuticals plc announced the completion of patient enrollment in REVITALYZ, a Phase 3 trial evaluating LUMRYZTM (sodium oxybate) extended-release oral suspension as a potential treatment for idiopathic hypersomnia (IH)."

What conditions do Avadel Pharmaceuticals' current drugs treat?

Currently, Avadel Pharmaceuticals has one therapy (LUMRYZ (sodium oxybate)) targeting the following condition: Extended-release sodium oxybate medication.