The associate clinical professor at the University of South Carolina School of Medicine discussed how JZP-258’s clinical profile has expanded since its original approval for narcolepsy, and whether it makes sense for all patients to consider. [WATCH TIME: 3 minutes]
WATCH TIME: 3 minutes
"I take to mind the fact that the FDA said this is a clinically superior drug. It’s a safer drug, it has lower sodium, and it’s still oxybate, the same moiety. Now, we’ve got clinical experience with the drug in terms of transitioning patients from Xyrem to Xywav, the lower sodium moiety. For most people, it’s gram-for-gram and fairly easy for patients to understand."
In July 2020, the FDA approved JZP-258 (Xywav; Jazz Pharmaceutical), an oral solution of calcium, magnesium, potassium, and sodium oxybates, for the treatment of cataplexy or excessive daytime sleepiness (EDS) in patients 7 years of age or older with narcolepsy. The oxybate product contains a unique composition of cations resulting in 92% less sodium or approximately 1000 to 1500 mg/night, than sodium oxybate (Xyrem; Jazz), the only approved medication for that indication at the time.
A little more than a year later, the FDA approved an expanded indication of the drug to include patients with idiopathic hypersomnia, becoming the first treatment approved for this indication. Since its original approval, the therapeutic has been featured in numerous analyses further demonstrating its efficacy and safety in both populations, including some presented at this year’s 2022 SLEEP Annual Meeting, June 4-8, in Charlotte, North Carolina.
Richard Bogan, MD, FCCP, FAASM, was the lead investigator for the phase 3 study that led to JZP-258’s approval in narcolepsy. Bogan, associate clinical professor at the University of South Carolina School of Medicine, and associate clinical professor, Medical University of South Carolina, sat down with NeurologyLive® at the meeting to discuss the advantages of low-sodium oxybate, and the improved overall knowledge of the drug since it first hit the market. He also discussed why the sodium content remains a huge factor when considering multiple different treatment options for patients with narcolepsy.