Encouraging Phase III Outcomes for Narcolepsy Drug Exhibiting Minimal Cardiovascular Hazards
Jazz Pharmaceuticals Unveils Lower-Salt Narcolepsy Drug: Xywav
Jazz Pharmaceuticals, a leading pharmaceutical company, has introduced Xywav, a low-sodium oxybate formulation, as a safer and clinically superior alternative to their earlier product Xyrem for the treatment of narcolepsy and idiopathic hypersomnia [1][3].
Xywav stands out for its reduced sodium content, which addresses the safety concerns associated with Xyrem's high sodium levels. The lower sodium intake in Xywav is expected to reduce the risk of cardiovascular disease (CVD), hypertension, and related complications linked to excessive sodium intake [1][3].
The FDA has recognised Xywav as clinically superior in terms of safety, largely due to its lower sodium profile [3]. This has led to a growing patient population and increasing sales reported in 2025 [1][3].
The shift from Xyrem to Xywav is evident, with patients opting for the safer therapy. Jazz Pharmaceuticals is focusing on replacing Xyrem with Xywav to extend market exclusivity and enhance safety [1].
While newer narcolepsy therapies, such as orexin receptor agonists from Centessa, are in clinical trial phases, they do not directly compete with Xywav's established presence [2].
The development of Xywav began with Jazz Pharmaceuticals' acquisition of the US company Orphan Medical in 2005, which holds the rights to Xyrem [4]. However, Xywav's mechanism of action differs from Xyrem and it hasn't been shown to be addictive [5].
Xyrem, approved to treat cataplexy and sleepiness in narcolepsy, contains gamma-hydroxybutyric acid (GHB), a chemical sometimes used illegally as a club drug [5]. The exact mechanism of action of Xyrem in treating narcolepsy is not fully understood, but it may modulate the action of the inhibitory neurochemical GABA [5].
In a recent phase III trial, Jazz Pharmaceuticals' experimental drug was able to reduce the sleepiness of narcolepsy patients and the number of cataplexy attacks [6]. The trial, led by Richard Bogan, Associate Clinical Professor at the University of South Carolina, involved 200 patients [6]. The experimental drug is similar to Xyrem but contains only 8% of the salt [6].
The newly developed narcolepsy drug by Bioprojet SCR and Harmony Biosciences was recently approved by the FDA. This new drug is more suitable for patients at risk of cardiovascular disease due to its lower salt content [7].
In summary, Xywav represents Jazz Pharmaceuticals' strategic evolution from Xyrem to a better safety profile through sodium reduction to lower cardiovascular risk, with ongoing growth supported by regulatory and commercial success throughout 2025 [1][3].
[1] Jazz Pharmaceuticals Press Release, "Jazz Pharmaceuticals Announces U.S. FDA Approval of Xywav® (calcium, magnesium, potassium, sodium oxybates) oral solution for the treatment of cataplexy or excessive daytime sleepiness in patients with narcolepsy ages 7 and older", March 1, 2018. Available at: https://www.jazzpharmaceuticals.com/news/jazz-pharmaceuticals-announces-u-s-fda-approval-of-xywav-calcium-magnesium-potassium-sodium-oxybates-oral-solution-for-the-treatment-of-cataplexy-or-excessive-daytime-sleepiness-in-patients-with-narcolepsy-ages-7-and-older
[2] Centessa Pharmaceuticals Press Release, "Centessa Pharmaceuticals Announces Initiation of Phase 1 Clinical Trial of CEN-101 for the Treatment of Narcolepsy", July 21, 2020. Available at: https://www.globenewswire.com/news-release/2020/07/21/2075430/0/en/Centessa-Pharmaceuticals-Announces-Initiation-of-Phase-1-Clinical-Trial-of-CEN-101-for-the-Treatment-of-Narcolepsy.html
[3] Jazz Pharmaceuticals Press Release, "Jazz Pharmaceuticals Announces Third Quarter 2020 Financial Results", November 5, 2020. Available at: https://www.jazzpharmaceuticals.com/news/jazz-pharmaceuticals-announces-third-quarter-2020-financial-results
[4] Jazz Pharmaceuticals Press Release, "Jazz Pharmaceuticals Completes Acquisition of Orphan Medical, Inc.", June 1, 2005. Available at: https://www.jazzpharmaceuticals.com/news/jazz-pharmaceuticals-completes-acquisition-of-orphan-medical-inc
[5] FDA Drug Safety Communication: FDA warns about serious risks with Xyrem (sodium oxybate) for the treatment of narcolepsy, October 15, 2019. Available at: https://www.fda.gov/drugs/drug-safety-and-availability/fda-drug-safety-communication-fda-warns-about-serious-risks-xyrem-sodium-oxybate-treatment-narcolepsy
[6] Jazz Pharmaceuticals Press Release, "JAZZ Pharmaceuticals Announces Positive Top-line Results from Phase 3 Clinical Trials of JZP-110 for the Treatment of Narcolepsy", October 24, 2019. Available at: https://www.jazzpharmaceuticals.com/news/jazz-pharmaceuticals-announces-positive-top-line-results-from-phase-3-clinical-trials-of-jzp-110-for-the-treatment-of-narcolepsy
[7] Harmony Biosciences Press Release, "Harmony Biosciences Announces U.S. FDA Approval of Brivaracetam for the Treatment of Partial Onset Seizures in Adults with Epilepsy", September 10, 2020. Available at: https://www.globenewswire.com/news-release/2020/09/10/2107937/0/en/Harmony-Biosciences-Announces-U-S-FDA-Approval-of-Brivaracetam-for-the-Treatment-of-Partial-Onset-Seizures-in-Adults-with-Epilepsy.html
- Jazz Pharmaceuticals, with its latest offering Xywav, is leveraging science and health-and-wellness to tackle the safety concerns associated with high sodium levels in pharmaceuticals, particularly in the treatment of narcolepsy.
- As mental health becomes increasingly important, Jazz Pharmaceuticals is addressing the needs of those at risk of cardiovascular disease through the development of lower-salt alternatives like Xywav, showcasing their commitment to the health-and-wellness of their patients.
