KemPharm has topline results from abuse-potential trial of med

KemPharm announced topline results from its intranasal, or IN, human abuse potential, or HAP, clinical trial of serdexmethylphenidate, the major active pharmaceutical ingredient in KP415, KemPharm’s investigational product candidate for the treatment of ADHD. In the IN HAP trial, SDX produced significantly lower scores on the primary endpoint, maximal drug liking, and other abuse-related endpoints, compared to intranasal d-methylphenidate hydrochloride, indicating that SDX is not efficiently converted to active d-methylphenidate when snorted. KemPharm will present the data from all three HAP trials, as well as tampering study results, to the FDA as part of its human abuse potential assessment for SDX in the KP415 new drug application, or NDA. During the review process, the FDA will recommend a controlled substance schedule for SDX to the Drug Enforcement Agency, or DEA. If KP415 is approved, the DEA must subsequently confirm the schedule for SDX, and KemPharm believes that the entirety of the data may support a lower schedule compared to other currently available methylphenidate-based ADHD products. Furthermore, since the FDA has required KemPharm to conduct all three HAP trials, KemPharm anticipates that data from these trials may likely be included in the label.

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