Drugs / Sodium Oxybate
Sodium Oxybate
Regulatory milestones approvals, filings & regulatory actions · 12 recorded
| Milestone | Jurisdiction | Brand | Indication | Date | Sentence it was read from |
|---|---|---|---|---|---|
| Filed fibromyalgia 3 milestones | |||||
| Rejected (CRL) | US (FDA) | — | fibromyalgia | 2010-10-11 | “complete response letter (CRL) regarding the company's New Drug Application (NDA) for JZP-6 (sodium oxybate) for the treatment of fibromyalgia.” jazzpharma.com ↗ |
| Filed | EU (EMA) | Xyrem | fibromyalgia | 2010-08-10 | “UCB announced that it has filed an application for approval of Xyrem (sodium oxybate) for the treatment of fibromyalgia with the European Medicines Agency (EMA).” jazzpharma.com ↗ |
| Filed | US (FDA) | — | fibromyalgia | 2010-02-18 | “the U.S. Food and Drug Administration (FDA) has accepted for filing the New Drug Application (NDA) for JZP-6 (sodium oxybate) for the treatment of fibromyalgia.” jazzpharma.com ↗ “In February 2010, the FDA accepted for filing and review the New Drug Application (NDA) of JZP-6 (sodium oxybate) for the treatment of fibromyalgia.” jazzpharma.com ↗ |
| Filed idiopathic hypersomnia 1 milestone | |||||
| Filed | US (FDA) | Xywav | idiopathic hypersomnia | 2021-08-03 | “FDA has granted Priority Review Designation and accepted the supplemental New Drug Application (sNDA) for Xywav in adult patients with idiopathic hypersomnia (IH).” jazzpharma.com ↗ |
| Filed narcolepsy 1 milestone | |||||
| Filed | US (FDA) | Xyrem | narcolepsy | 2018-04-27 | “In April 2018 , the company submitted a supplemental NDA to the FDA seeking marketing approval for Xyrem in the treatment of pediatric narcolepsy patients.” jazzpharma.com ↗ |
| Approved Indication not stated 4 milestones | |||||
| Label expansion | US (FDA) | LUMRYZ | — | 2024-10-16 | fda.gov ↗ |
| Label expansions (4) | US (FDA) | XYREM | — | 2005-11-18 – 2020-09-25 | fda.gov ↗ |
| Approved | EU (EMA) | Xyrem | — | 2005-10-13 | europa.eu ↗ |
| Approved | US (FDA) | XYREM | — | 2002-07-17 | fda.gov ↗ |
Trials 36
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 01 trial | ||||||
| Phase 0 | NCT03626727 | Sep 2020 | hypersomnia, narcolepsy, traumatic brain injury | Brigham and Women's Hospital | Withdrawn | No outcome recorded Stop: Enrollment |
| Phase 12 trials | ||||||
| Phase 1 | NCT07041203 | Oct 2026 → Sep 2027 expected | spasmodic dystonia | Kristina Simonyan | Not yet recruiting | No outcome recorded |
| Phase 1 | NCT00345800 | Apr 2006 → Jan 2008 | narcolepsy-cataplexy syndrome | UCB Pharma | Completed | No outcome recorded |
| Phase 1/21 trial | ||||||
| Phase 1/2 | NCT00931164 | Aug 2009 → Jan 2011 | alternating hemiplegia of childhood | University of Utah | Completed | No outcome recorded |
| Phase 28 trials · 2 met primary | ||||||
| Phase 2 | NCT06809803 | Oct 2025 → Jun 2027 expected | narcolepsy 1 | Stanford University | Recruiting | No outcome recorded |
| Phase 2 | NCT02111122 | Apr 2014 → Apr 2016 | sleep-wake disorder | Christian Baumann | Completed | No outcome recorded |
| Phase 2 | NCT01961297 | Jul 2012 → Jun 2017 | spasmodic dystonia | Kristina Simonyan | Completed | No outcome recorded |
| Phase 2 | NCT00594256 | May 2008 → Apr 2009 | insomnia, schizophrenia | Nathan Kline Institute for Psychiatric Research | Completed | No outcome recorded |
| Phase 2 | NCT00598078 | Dec 2007 → Aug 2008 | essential tremor | Jazz Pharmaceuticals | Completed | Met primary |
| Phase 2 | NCT00330291 | Aug 2005 → Aug 2006 | post-traumatic stress disorder | State University of New York - Upstate Medical University | Withdrawn | No outcome recorded Stop: Enrollment |
| Phase 2 | NCT00641186 | Sep 2004 → Jul 2008 | Parkinson disease | Baylor College of Medicine | Completed | No outcome recorded |
| Phase 2 | NCT00087555 | Jul 2004 → Apr 2005 | fibromyalgia | Jazz Pharmaceuticals | Completed | Met primary |
| Phase 2/33 trials · 1 met primary | ||||||
| Phase 2/3 | NCT03597555 | Oct 2018 → Apr 2023 | idiopathic hypersomnia | University Hospital, Montpellier | Completed | Met primary |
| Phase 2/3 | NCT03292458 | Jan 2018 → Dec 2021 | spasmodic dystonia | Kristina Simonyan | Completed | No outcome recorded |
| Phase 2/3 | NCT00514995 | Aug 2007 → Apr 2011 | binge eating disorder | Lindner Center of HOPE | Completed | No outcome recorded |
| Phase 310 trials · 5 met primary | ||||||
| Phase 3 | NCT02720744 | Nov 2016 → Mar 2020 | hypersomnia, narcolepsy-cataplexy syndrome | Avadel | Completed | Met primary |
| Phase 3 | NCT02637648 | Dec 2015 → Sep 2016 | cluster headache syndrome | Ramin Khatami | Unknown | No outcome recorded |
| Phase 3 | NCT02221869 | Oct 2014 → Feb 2017 | narcolepsy-cataplexy syndrome | Jazz Pharmaceuticals | Completed | Met primary |
| Phase 3 | NCT00803023 | Mar → Jul 2010 | fibromyalgia | Jazz Pharmaceuticals | Completed | No outcome recorded |
| Phase 3 | NCT00423605 | Dec 2006 → Jan 2010 | fibromyalgia | Jazz Pharmaceuticals | Completed | No outcome recorded |
| Phase 3 | NCT00423813 | Dec 2006 → Apr 2009 | fibromyalgia | Jazz Pharmaceuticals | Completed | Met primary |
| Phase 3 | NCT00371137 | Aug 2006 → Sep 2008 | fibromyalgia | Jazz Pharmaceuticals | Completed | Met primary |
| Phase 3 | NCT00132873 | Oct 2004 → Sep 2007 | narcolepsy | Jazz Pharmaceuticals | Completed | No outcome recorded |
| Phase 3 | NCT00066170 | Apr 2003 → Jul 2004 | narcolepsy | Jazz Pharmaceuticals | Completed | Met primary |
| Phase 3 | NCT00049803 | Dec 2000 → Apr 2004 | narcolepsy | Orphan Medical | Completed | No outcome recorded |
| Phase 49 trials · 3 met primary | ||||||
| Phase 4 | NCT05085873 | Oct 2021 → Oct 2023 | — | Centre Hospitalier Intercommunal de Toulon La Seyne sur Mer | Completed | Met primary |
| Phase 4 | NCT02637076 | Jan 2016 → Jan 2020 | narcolepsy-cataplexy syndrome | Centre for Addiction and Mental Health | Completed | No outcome recorded |
| Phase 4 | NCT02055898 | Apr 2014 → Aug 2015 | myalgic encephalomeyelitis/chronic fatigue syndrome | Imperial College London | Completed | No outcome recorded |
| Phase 4 | NCT01584934 | Jun 2013 → Jun 2015 | myalgic encephalomeyelitis/chronic fatigue syndrome | University Hospital, Ghent | Withdrawn | No outcome recorded |
| Phase 4 | NCT00506974 | May 2007 → Jun 2008 | — | St. Luke's Hospital, Chesterfield, Missouri | Completed | No outcome recorded |
| Phase 4 | NCT00086281 | Nov 2003 → Jun 2005 | obstructive sleep apnea syndrome | Jazz Pharmaceuticals | Completed | Met primary |
| Phase 4 | NCT02090504 | Feb 2002 → Apr 2009 | alcohol dependence, alcohol withdrawal | Catholic University of the Sacred Heart | Completed | No outcome recorded |
| Phase 4 | NCT04648423 | Jul 2001 → Mar 2011 | alcohol dependence | Laboratorio Farmaceutico Ct S.r.l. | Completed | Met primary |
| Phase 4 | NCT00706186 | — | Alzheimer disease | Clayton Sleep Insititute | Terminated | No outcome recorded |
| Phase not applicable2 trials · 1 missed | ||||||
| — | NCT07794982 | Aug 2026 → Dec 2027 expected | — | Jingsheng Lou | Not yet recruiting | No outcome recorded |
| — | NCT02063217 | Dec 2013 → Jul 2016 | — | Washington University School of Medicine | Completed | Missed primary |
| Comparator or background therapy5 trials | ||||||
| Phase 1 | NCT02215499 Comparator | Jul → Nov 2014 | narcolepsy | Concert Pharmaceuticals | Completed | No outcome recorded |
| Phase 2 | NCT00744393 Comparator | Oct 2008 → Dec 2009 | — | Tufts Medical Center | Withdrawn | No outcome recorded Stop: Business |
| Phase 2 | NCT00383643 Comparator | May 2006 → Dec 2009 | sleep disorder, initiating and maintaining sleep | Stanford University | Completed | No outcome recorded |
| Phase 4 | NCT04006925 Comparator | Sep 2019 → Feb 2022 | Parkinson disease, REM sleep behavior disorder | Stanford University | Completed | No outcome recorded |
| Phase 4 | NCT00498485 Comparator | May 2007 → Dec 2008 | myalgic encephalomeyelitis/chronic fatigue syndrome | University of Medicine and Dentistry of New Jersey | Terminated | No outcome recorded |
News releases announcing trial results or a regulatory action · 21
| Date | Issuer | Release |
|---|---|---|
| 2026-05-12 | Alkermes, Inc. | Results Alkermes Announces Positive Topline Results From REVITALYZ℠ Phase 3 Study Evaluating LUMRYZ® (sodium oxybate) Extended-Release in Adults With Idiopathic Hypersomnia alkermes.com ↗
LUMRYZ met the study’s primary endpoint, demonstrating statistically significant improvements in excessive daytime sleepiness compared to placebo as measured by the change in Epworth Sleepiness Scale (ESS)1 score (p<0.0001). |
| 2025-09-11 | Impax Laboratories, LLC | Regulatory Amneal Receives U.S. FDA Approval of Sodium Oxybate Oral Solution amneal.com ↗
Amneal Pharmaceuticals, Inc. (“Amneal” or the “Company”) today announced the U.S. Food and Drug Administration (FDA) approval of Amneal’s sodium oxybate oral solution 500 mg/mL Abbreviated New Drug Application (ANDA) which references Jazz Pharmaceuticals’ Xyrem ® . |
| 2024-04-10 | Jazz Pharmaceuticals | Results Jazz Pharmaceuticals to Showcase Expansive Neuroscience Portfolio at American Academy of Neurology Annual Meeting jazzpharma.com ↗
One poster reporting the final results from the SEGUE study of adults with narcolepsy transitioning from Xyrem ® (sodium oxybate) oral solution, a high-sodium oxybate, to Xywav , showing that participants switched from high-sodium to low-sodium oxybate with minimal adjustments to their dosing. |
| 2023-10-18 | Jazz Pharmaceuticals | Results Jazz Pharmaceuticals to Present Latest Advancements in Sleep Medicine at World Sleep 2023 jazzpharma.com ↗
The oral presentations include findings from the real-world TENOR study, which demonstrated individualized dosing strategies for twice-nightly oxybate treatment in narcolepsy. |
| 2023-09-11 | Jazz Pharmaceuticals | Results Jazz Pharmaceuticals Showcases Impact of Sleep Medicine Portfolio at Psych Congress 2023 jazzpharma.com ↗
The review found that oxybate improved measures of sleep architecture and disrupted nighttime sleep in narcolepsy patients, independent of dosing regimen or prior oxybate experience. |
| 2023-05-31 | Jazz Pharmaceuticals | Results Jazz Pharmaceuticals Demonstrates Continued Leadership in Sleep Medicine with New Data Presentations at SLEEP 2023 jazzpharma.com ↗ |
| 2022-01-05 | Jazz Pharmaceuticals | Results Lancet Neurology Publishes Positive, Pivotal Phase 3 Data of Xywav® (calcium, magnesium, potassium, and sodium oxybates) Oral Solution for Idiopathic Hypersomnia jazzpharma.com ↗ |
| 2020-10-08 | Jazz Pharmaceuticals | Results Jazz Pharmaceuticals Announces Positive Top-line Results from Phase 3 Study of Xywav™ (calcium, magnesium, potassium, and sodium oxybates) Oral Solution in Adult Patients with Idiopathic Hypersomnia jazzpharma.com ↗
Jazz Pharmaceuticals plc (Nasdaq: JAZZ) today announced positive top-line results from the Phase 3 double-blind, multicenter, placebo-controlled, randomized withdrawal study evaluating the efficacy and safety of an investigational use of Xywav™ (calcium, magnesium, potassium, and sodium oxybates) oral solution in adult patients with idiopathic hypersomnia. |
| 2018-10-29 | Jazz Pharmaceuticals | Regulatory Jazz Pharmaceuticals Announces FDA Approval of Xyrem® (sodium oxybate) for the Treatment of Cataplexy or Excessive Daytime Sleepiness in Pediatric Narcolepsy Patients jazzpharma.com ↗
This approval of Xyrem in pediatric patients is a significant step forward for the narcolepsy community as we work to elevate awareness of the condition in children and ensure patients, both pediatric and adult, have meaningful treatment options available. |
| 2018-06-27 | Jazz Pharmaceuticals | Regulatory Jazz Pharmaceuticals Announces FDA Acceptance of Supplemental New Drug Application for Xyrem® (sodium oxybate) to Treat Cataplexy and Excessive Daytime Sleepiness in Pediatric Narcolepsy Patients jazzpharma.com ↗
the U.S. Food and Drug Administration ( FDA ) accepted for priority review its supplemental new drug application (sNDA) |
| 2018-06-03 | Jazz Pharmaceuticals | Results Jazz Pharmaceuticals Presents Long-Term Safety and Efficacy Data for Xyrem® (sodium oxybate) in Pediatric Patients with Narcolepsy with Cataplexy jazzpharma.com ↗
The results were presented in a poster today at the 32nd Annual Meeting of the Associated Professional Sleep Societies and will be featured in an oral presentation on June 5 at 2:45 p.m. ET . |
| 2018-05-01 | Jazz Pharmaceuticals | Regulatory Jazz Pharmaceuticals Submits Supplemental New Drug Application for Xyrem® (sodium oxybate) to Treat Cataplexy and Excessive Daytime Sleepiness in Pediatric Narcolepsy Patients jazzpharma.com ↗
Jazz Pharmaceuticals plc (Nasdaq: JAZZ) today announced that it has filed a supplemental new drug application (sNDA) with the U.S. Food and Drug Administration ( FDA ) on April 27, 2018 seeking revised labeling for Xyrem® (sodium oxybate) oral solution, CIII, to include an indication to treat cataplexy and EDS in pediatric narcolepsy patients. |
| 2017-04-24 | Jazz Pharmaceuticals | Results Jazz Pharmaceuticals Announces Positive Results from the Phase 2/3 EXPRESS Study of Xyrem in Pediatric Patients with Narcolepsy with Cataplexy jazzpharma.com ↗
Xyrem demonstrated statistically significant differences in the primary and key secondary efficacy endpoints that measured the change in the weekly number of cataplexy attacks, the Clinical Global Impression of Change scale (CGIc) for the severity of cataplexy, and the Epworth Sleepiness Scale (ESS) for children and adolescents ( CHAD ) score compared to placebo. |
| 2010-10-11 | Jazz Pharmaceuticals | Regulatory Jazz Pharmaceuticals Receives FDA Complete Response Letter Regarding JZP-6 for Treatment of Fibromyalgia jazzpharma.com ↗
The CRL states that the FDA cannot approve the NDA in its present form. |
| 2010-10-05 | Jazz Pharmaceuticals | Regulatory Jazz Pharmaceuticals Announces Paragraph IV ANDA Filing for Xyrem jazzpharma.com ↗
Jazz Pharmaceuticals, Inc. (Nasdaq: JAZZ) today announced that the website of the US Food and Drug Administration indicates that an Abbreviated New Drug Application (ANDA) for a generic version of Xyrem® (sodium oxybate oral solution) 500 mg/ml was submitted on July 8, 2010. |
| 2010-06-24 | Jazz Pharmaceuticals | Regulatory Jazz Pharmaceuticals' JZP-6 to be Reviewed at a Joint Meeting of the FDA's Arthritis Advisory Committee and Drug Safety and Risk Management Advisory Committee on August 20, 2010 jazzpharma.com ↗
Jazz Pharmaceuticals, Inc. (Nasdaq: JAZZ) announced today that the U.S. Food and Drug Administration's (FDA) Arthritis Advisory Committee and Drug Safety and Risk Management Advisory Committee will review JZP-6 (sodium oxybate) for the treatment of fibromyalgia at a joint meeting on August 20, 2010. |
| 2010-02-18 | Jazz Pharmaceuticals | Regulatory Jazz Pharmaceuticals Announces FDA Acceptance of its New Drug Application for JZP-6 (sodium oxybate) for the Treatment of Fibromyalgia jazzpharma.com ↗
Jazz Pharmaceuticals, Inc. (Nasdaq: JAZZ) announced today that the U.S. Food and Drug Administration (FDA) has accepted for filing the New Drug Application (NDA) for JZP-6 (sodium oxybate) for the treatment of fibromyalgia. |
| 2009-12-15 | Jazz Pharmaceuticals | Regulatory Jazz Pharmaceuticals Submits New Drug Application for JZP-6 (sodium oxybate) for the Treatment of Fibromyalgia jazzpharma.com ↗
Jazz Pharmaceuticals, Inc. (Nasdaq: JAZZ) announced it has submitted a New Drug Application (NDA) to the U.S. Food and Drug Administration for JZP-6 (sodium oxybate oral solution) for the treatment of fibromyalgia. |
| 2009-06-24 | Jazz Pharmaceuticals | Results Jazz Pharmaceuticals and UCB Announce Second Phase III Study of Sodium Oxybate in Patients With Fibromyalgia Meets Primary Endpoints jazzpharma.com ↗
Jazz Pharmaceuticals, Inc. (Nasdaq: JAZZ) and UCB (Euronext Brussels: UCB) announced today positive preliminary top-line results from the second of two Phase III clinical trials of sodium oxybate (JZP-6) for the treatment of fibromyalgia. |
| 2009-06-15 | Jazz Pharmaceuticals | Results Data Suggest Sodium Oxybate Significantly Improves Pain and the Core Symptoms of Fibromyalgia jazzpharma.com ↗
"The data showed that sodium oxybate improves the key symptoms of fibromyalgia: pain, fatigue, and sleep disturbances," said Dr. Todd Swick, one of the study's investigators and Medical Director of the Houston Sleep Center and Assistant Clinical Professor of Neurology at the University of Texas-Houston School of Medicine. |
| 2008-11-20 | Jazz Pharmaceuticals | Results Jazz Pharmaceuticals and UCB Announce Positive Phase III Results for Sodium Oxybate (JZP-6) in Fibromyalgia jazzpharma.com ↗
The randomized, double-blind, placebo-controlled study achieved its primary endpoints, demonstrating that sodium oxybate significantly decreased pain and fatigue, and improved daily function, in patients with fibromyalgia. |
All press releases naming this drug 37 releases
Evidence & citations 10 cited values
Every value below carries the sentence it was read from. 47 sources stand behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | sodium oxybate | “Once-nightly sodium oxybate (ON-SXB; LUMRYZ™; FT218) treatment significantly improved the coprimary endpoints of mean sleep latency on the Maintenance of Wakefulness Test...” PMID 40111739 ↗ Mar 202537“This 14-week, phase 3, double-blind, randomized, controlled trial evaluated sodium oxybate (SXB) 4.5 and 6g per night versus placebo in patients with fibromyalgia (FM).” PMID 21397402 ↗ Mar 2011 “Xyrem (sodium oxybate) is an agent with the propensity to improve slow wave sleep and sleep efficiency.” NCT00330291 ↗ “Safety and Efficacy Study of Xyrem® (Sodium Oxybate) in Subjects With Fibromyalgia.” NCT00423605 ↗ “Xyrem (sodium oxybate) oral solution” NCT00132873 ↗ “Xyrem (Sodium Oxybate) Oral Solution” NCT00086281 ↗ “Xyrem® (Sodium Oxybate)” NCT00423813 ↗ |
| Known as | Brand name: Xyrem | “Brand name: Xyrem” NCT02111122 ↗ |
| Known as | FT218 | “Once-nightly sodium oxybate (ON-SXB; LUMRYZ™; FT218) treatment significantly improved the coprimary endpoints of mean sleep latency on the Maintenance of Wakefulness Test...” PMID 40111739 ↗ Mar 2025 |
| Known as | LUMRYZ | “Once-nightly sodium oxybate (ON-SXB; LUMRYZ™; FT218) treatment significantly improved the coprimary endpoints of mean sleep latency on the Maintenance of Wakefulness Test...” PMID 40111739 ↗ Mar 2025 |
| Known as | ON-SXB | “Once-nightly sodium oxybate (ON-SXB; LUMRYZ™; FT218) treatment significantly improved the coprimary endpoints of mean sleep latency on the Maintenance of Wakefulness Test...” PMID 40111739 ↗ Mar 2025 |
| Known as | SMO | “Sodium oxybate (SMO) has been tested as a treatment for AWS with encouraging results.” NCT02090504 ↗1“Sodium oxybate (SMO) has been shown to be effective in the maintenance of abstinence” PMID 35796481 ↗ Jul 2022 |
| Known as | SXB | “The long-term safety and therapeutic response of sodium oxybate (SXB) in fibromyalgia syndrome (FM) patients were assessed for a combined period of up to 1 year in a...” PMID 24286114 ↗ Nov 20134“STUDY OBJECTIVES: To determine the time course and duration of common, early-onset treatment-emergent adverse events (TEAEs) associated with sodium oxybate (SXB) use in adults...” PMID 32356515 ↗ Sep 2020 “This 14-week, phase 3, double-blind, randomized, controlled trial evaluated sodium oxybate (SXB) 4.5 and 6g per night versus placebo in patients with fibromyalgia (FM).” PMID 21397402 ↗ Mar 2011 “we aimed to evaluate efficacy and safety of sodium oxybate (SXB) in IH.” PMID 40359459 ↗ May 2025 “Sodium oxybate (SXB), a gamma-aminobutyric acid (GABA)-B agonist” PMID 37052688 ↗ Aug 2023 |
| Known as | Xyrem | “Participants will take Non-Extended-release Oxybates (Xyrem oral solution or Xywav oral solution) 4.5-9 g orally per night (divided into two doses, once before bedtime and...” NCT06809803 ↗14“We conducted an open-label study in 23 SD and 22 SD/VT patients to examine the effects of sodium oxybate (Xyrem), an oral agent with therapeutic effects similar to those of...” PMID 27808415 ↗ Nov 2016 “Safety and Efficacy of Xyrem Oral Solution (Sodium Oxybate) Compared With Placebo in Narcoleptic Patients” NCT00049803 ↗ “Safety and Efficacy Study of Xyrem® (Sodium Oxybate) in Subjects With Fibromyalgia.” NCT00423605 ↗ “Xyrem (Sodium Oxybate), oral solution 500mg/mL” NCT03597555 ↗ “Sodium Oxybate Oral Solution [Xyrem]” NCT03626727 ↗ “Xyrem (sodium oxybate) oral solution” NCT00087555 ↗ “sodium oxybate (Xyrem®)” NCT03292458 ↗ |
| Action | Activate | “a gamma-aminobutyric acid type b (GABAB) and a g-hydroxybutyric acid (GHB) receptor agonist” NCT00594256 ↗ |
| Route | Oral | “Orally Administered Xyrem (Sodium Oxybate)” NCT00049803 ↗ |