Zevra Therapeutics Presents Full Data Set on the Cardiovascular Safety and Pharmacokinetics of SDX, the sole API in KP1077, in Healthy Volunteers at Psych Congress 2023

CELEBRATION, Fla., Sept. 09, 2023 (GLOBE NEWSWIRE) -- Zevra Therapeutics, Inc. (NasdaqGS: ZVRA) (Zevra, or the Company), a rare disease therapeutics company, today announced a poster presentation featuring study data that underscores the cardiovascular safety profile of serdexmethylphenidate (SDX), the sole active pharmaceutical ingredient (API) in KP1077, Zevra’s investigational candidate for the treatment for idiopathic hypersomnia (IH), at the Psych Congress 2023 taking place September 6-10, 2023, in Nashville, Tennessee.

“The study results affirm that SDX is safe and well-tolerated at higher doses and has no greater cardiovascular safety risk than other methylphenidate products currently being used off-label for the treatment of IH while providing higher overall exposure levels of d-MPH. These data play an important role in the development of KP1077 as we work to address the unmet needs of people living with rare sleep disorders,” said Rene Braeckman, Ph.D., Sr. Vice President of Clinical Development at Zevra.

In recognition of the research presented in the poster, Zevra’s work was selected as a finalist for display at the Psych Congress Poster Award Reception on Saturday, September 9, from 6:45 p.m. to 8:00 p.m. CT.

The poster presentation titled, “Cardiovascular (CV) Safety and Pharmacokinetics (PK) of Serdexmethylphenidate (SDX), a Prodrug of d-Methylphenidate (d-MPH), Compared to Ritalin and Ritalin LA in a Single-Dose Crossover Study in Healthy Volunteers,” will report on the cardiovascular effects and pharmacokinetics of the 80 mg and 200 mg dose levels of SDX, a prodrug of d-methylphenidate (d-MPH), compared to immediate-release racemic methylphenidate (Ritalin) and long-acting racemic methylphenidate (Ritalin LA) from an open-label, single-dose, 4-treatment, 4-period, randomized, crossover study in healthy volunteers. The immediate-release Ritalin total dose (2 x 40 mg), the 80 mg dose of Ritalin LA and 80 mg dose of SDX represent approximately the same amount of d-MPH, the active ingredient of interest. Results of the study demonstrate that at an SDX dose (200 mg) 2.5-fold higher than the molar-equivalent Ritalin doses (80 mg), the peak exposure to d-MPH occurred later and was lower. In addition, both doses of SDX were generally better tolerated compared to Ritalin and fewer subjects experienced cardiovascular adverse events after SDX compared to Ritalin. Lastly, vital signs after a single oral dose of 200 mg SDX (the highest dose tested) were comparable to Ritalin IR 80 mg and Ritalin LA 80 mg. The results demonstrate a robust safety profile for SDX, positioning it as a promising option for treating sleep disorders characterized by excessive daytime sleepiness.