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Dear Editor,
We thank Dr Roth for his interest in our article “Implications of Oxybate Dosing Regimen for Sleep, Sleep Architecture, and Disrupted Nighttime Sleep in Patients With Narcolepsy: A Commentary” [1] and for bringing the error in Table 2 of that article to our attention [2]. We agree wholeheartedly that accurate data must be provided for clinicians and researchers to evaluate the outcomes of the clinical trials for the different oxybate formulations. In this letter we also provide the corrected Table 2, where the cited values have now been updated to align with the modified intent-to-treat population for each of the three parameters previously taken from the Roth et al. 2022 article [3]. It is worth noting that the differences between the subgroup and modified intent-to-treat populations were numerically small and that the correction of this error does not affect the interpretation of the data or conclusions drawn in our Commentary article. We hope that these corrections, along with the statements in our original Commentary article regarding the caveats related to cross-study comparisons, will allow readers to draw their own conclusions about the data and evidence regarding the implications of oxybate dosing regimen on sleep, sleep architecture, and disrupted nighttime sleep in patients with narcolepsy.
Dr Roth also refers to our discussion around the potential benefits of increased exposure to oxybate in the second half of the night in patients with narcolepsy, and the corresponding increased slow-wave sleep during that period. In doing so, Dr Roth suggests that sodium oxybate for extended release (SXB-ER) might impart more “normal” sleep architecture in patients with narcolepsy (increased slow-wave sleep in the first half of the night, and lighter stages of sleep closer to awakening). However, if in fact oxybate imparts an important treatment effect by increasing slow-wave sleep, its ability to do so may be enhanced during periods of lower intrinsic slow-wave activity, such as the second half of the night. Currently, there is no evidence to support either speculation, suggesting a need for future research to address this data gap.
In summary, we have provided updates, which do not affect the overall conclusions of our Commentary article.
Data Availability
Data sharing is not applicable to this letter as no datasets were generated or analyzed during the current study.
References
Rosenberg R, Braceras R, Macfadden W, et al. Implications of oxybate dosing regimen for sleep, sleep architecture, and disrupted nighttime sleep in patients with narcolepsy: a commentary. Neurol Ther. 2023;12(6):1805–20.
Roth T. Letter to the Editor regarding: “Implications of oxybate dosing regimen for sleep, sleep architecture, and disrupted nighttime sleep in patients with narcolepsy: a commentary” by R. Rosenberg et al. Neurol Ther. 2024;13.
Roth T, Dauvilliers Y, Thorpy MJ, et al. Effect of FT218, a once-nightly sodium oxybate formulation, on disrupted nighttime sleep in patients with narcolepsy: results from the randomized phase III REST-ON trial. CNS Drugs. 2022;36(4):377–87.
Medical Writing and Editorial Assistance.
This letter was sponsored by Jazz Pharmaceuticals. Under the direction of the authors, Sean Anderson, PhD, and Michael J. Theisen, PhD, of Peloton Advantage, LLC, an OPEN Health company, provided medical writing and editorial support. Jazz Pharmaceuticals provided funding to Peloton Advantage for medical writing and editorial support.
Funding
In addition to supporting medical writing and editorial support, Jazz Pharmaceuticals provided funding for all fees relating to publication of the letter but no funding was received for the Rapid Service fees.
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Chad Ruoff contributed to the conception, drafting, and review of the letter. Shawn Candler contributed to the conception, drafting, and review of the letter. Jed Black contributed to the conception, drafting, and review of the letter.
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C Ruoff has served as an advisory board member for Jazz Pharmaceuticals, Eisai, Alkermes, and Takeda, and has received grant funding from Jazz Pharmaceuticals. S Candler is a full-time employee of Jazz Pharmaceuticals who, in the course of this employment, has received stock options exercisable for, and other stock awards of, ordinary shares of Jazz Pharmaceuticals, plc. J Black is a part-time employee of Jazz Pharmaceuticals and shareholder of Jazz Pharmaceuticals, plc.
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This letter is based on previously conducted studies and does not contain any new studies with human participants or animals performed by any of the authors.
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Ruoff, C., Candler, S. & Black, J. Response to Letter to the Editor Regarding “Implications of Oxybate Dosing Regimen for Sleep, Sleep Architecture, and Disrupted Nighttime Sleep in Patients With Narcolepsy: A Commentary”. Neurol Ther (2024). https://doi.org/10.1007/s40120-024-00611-y
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DOI: https://doi.org/10.1007/s40120-024-00611-y