KemPharm’s KP415 and Serdexmethylphenidate (SDX) Prodrug to be Featured in Multiple Sessions at the AACAP 2020 Virtual Meeting

CELEBRATION, Fla., Oct. 22, 2020 (GLOBE NEWSWIRE) -- KemPharm, Inc. (OTCQB: KMPH), a specialty pharmaceutical company engaged in the discovery and development of proprietary prodrugs, today announced that research involving KP415 and serdexmethylphenidate (SDX) will be featured in two oral presentations during the Annual American Academy of Child and Adolescent Psychiatry (AACAP) 2020 Virtual Meeting. In addition, research conducted by KemPharm’s scientific team related to patterns of abuse of prescription stimulant products will be presented during the poster session.   The two oral presentations will be delivered on October 23, 2020 as part of the “Research Pipeline: New Findings on Diagnostic and Therapeutics” session (2:00 p.m. to 4:00 p.m., ET).

KP415 is KemPharm’s investigational product candidate for the treatment of attention deficit hyperactivity disorder (ADHD). Serdexmethylphenidate (SDX) is KemPharm’s prodrug of d-methylphenidate (d-MPH). KP415 consists of SDX co-formulated with immediate-release d-MPH. A New Drug Application (NDA) for KP415 is currently under review with the U.S. Food and Drug Administration (FDA) with an anticipated PDUFA date of March 2, 2021.

“We are pleased that three studies involving KP415, the potentially advantageous properties of SDX, and the patterns of abuse of prescription stimulant products were accepted for scientific presentations at the AACAP 2020 Virtual Meeting,” said Travis Mickle, Ph.D., President and CEO of KemPharm. “Having two oral presentations and a poster session during this important scientific gathering demonstrates the amount of scientific interest in the potential for KP415 to address unmet needs for treating patients with ADHD. As the regulatory review of KP415 advances towards an expected March 2, 2021 PDUFA, we believe the research presented at AACAP 2020 provides additional information that will prove beneficial to potential future prescribers, including data affirming the lower abuse potential of SDX and the importance of minimizing such abuse.”

The first oral presentation, “Human Abuse Potential Assessment of Serdexmethylphenidate (SDX), A Novel Prodrug of d-Methylphenidate,” examines the human abuse potential of SDX in comparison to standard d-methylphenidate (d-MPH) products when administered by routes commonly reported by stimulant abusers (oral, intranasal and intravenous). To be presented by Lynn Webster, M.D., Vice President of Scientific Affairs at PRA Healthsciences, data from this comprehensive series of studies suggest that SDX may have a lower intrinsic abuse potential than d-MPH HCl when administered via the most common routes of abuse for methylphenidate (MPH) products.