Zevra Therapeutics, Inc. 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. 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-MP H), 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. About SDX and KP1077: Serdexmethylphen candidate (SDX) is Zevra's proprietary prodrug of d-methyl phenidate (d-MPH) and the U.S. Drug Enforcement Agency (DEA) has classified SDX, the sole API in KP1077, as a Schedule IV controlled substance based on evidence suggesting SDX has a lower potential for abuse when compared to d-MPH, a Schedule II controlled substance.

These forward-looking statements include without limitation statements regarding senior leadership and board member transitions and refreshment, or the timing thereof, and strategic and product development objectives, the potential sale of the Priority Review Voucher, the promise and potential impact of preclinical or clinical trial data, including without limitation the initiation, timing and results of any clinical trials or readouts, the content, information used for, timing or results of any IND applications and NDA submissions or resubmissions for arimoclomol, KP1077, or any other product candidates for any specific disease indication.