KemPharm Presents Poster at ACNP’s 57th Annual Meeting Highlighting the Intravenous Abuse Potential of Serdexmethylphenidate (SDX)

Findings suggest that SDX, a prodrug of d-methylphenidate, is unlikely to be attractive for intravenous abuse

CELEBRATION, Fla., Dec. 12, 2018 (GLOBE NEWSWIRE) — KemPharm, Inc. (NASDAQ: KMPH), a specialty pharmaceutical company engaged in the discovery and development of proprietary prodrugs, today announced that research assessing the intravenous (IV) abuse potential of serdexmethylphenidate (SDX), KemPharm’s prodrug of d-methylphenidate (d-MPH), will be presented by Megan Shram, Ph.D., at the 57^th Annual Meeting of the American College of Neuropsychopharmacology (ACNP). SDX is the major active pharmaceutical ingredient in KP415 and KP484, KemPharm’s co-lead clinical development product candidates intended for the treatment of attention-deficit/hyperactivity disorder (ADHD), as well as KP879, a newly developed product candidate designed for the treatment of Stimulant Use Disorder (SUD).

The poster, titled, “Assessment of the Intravenous Abuse Potential Of Serdexmethylphenidate (SDX), a Novel, Investigational Prodrug of D-Methylphenidate: Evidence from Nonclinical and Clinical Studies,” highlighted a series of in vitro and in vivo studies designed to examine the IV abuse potential of SDX.  Of importance:

• SDX, as the intact prodrug, had no discernible pharmacologic activity and was not readily converted to d-MPH in human whole blood, plasma, and liver fractions
   
• IV administration of SDX to rats and humans yielded very low systemic exposure to d-MPH
• IV administration of SDX to recreational stimulant abusers produced pharmacodynamic effects that were comparable to placebo and significantly lower than IV d-MPH HCl (at an equimolar dose) on multiple abuse-related endpoints

“The data presented at ACNP demonstrate that SDX, KemPharm’s prodrug of d-methylphenidate, possesses unique properties that may significantly limit its abuse potential when administered intravenously,” said Dr. Shram, Director at Altreos Research Partners and Adjunct Professor of Pharmacology at the University of Toronto.  Dr. Shram is the lead author for the poster and will present the data to the ACNP Annual Meeting attendees. 

“These results provide an important snapshot of the KP415 Human Abuse Potential (HAP) program, which suggested that SDX, the major active pharmaceutical ingredient of KP415, has lower abuse potential than relevant d-MPH comparators when administered intravenously, intranasally, or orally at high doses,” said Travis Mickle, Ph.D., President and Chief Executive Officer of KemPharm. “The ability to limit abuse potential is a key element to the value proposition of KP415, and we appreciate Dr. Shram’s presentation of these findings to the ACNP Annual Meeting attendees.  We remain on track to submit our New Drug Application for KP415 with the FDA as early as Q1 2019.”

KemPharm funded the study which was conducted by Altreos Research Partners.

About KemPharm:

KemPharm is a specialty pharmaceutical company focused on the discovery and development of proprietary prodrugs to treat serious medical conditions through its proprietary LAT^TM (Ligand Activated Therapy) technology.  KemPharm utilizes its proprietary LAT technology to generate improved prodrug versions of FDA-approved drugs as well as to generate prodrug versions of existing compounds that may have applications for new disease indications.  KemPharm’s product pipeline is focused on the high need areas of ADHD, pain, and other central nervous system disorders.  Its co-lead clinical development candidates are KP415 and KP484, both based on a prodrug of d-methylphenidate, but with differing extended-duration profiles intended for the treatment of ADHD.  In addition, KemPharm has received FDA approval for APADAZ^®, an immediate-release combination product containing benzhydrocodone, a prodrug of hydrocodone, and acetaminophen.  For more information on KemPharm and its pipeline of prodrug product candidates visit www.kempharm.com or connect with us on Twitter, LinkedIn, Facebook and YouTube.

About the ACNP:

The American College of Neuropsychopharmacology, ACNP, founded in 1961, is a professional organization of more than 1,100 leading scientists, including four Nobel Laureates. The mission of ACNP is to further research and education in neuropsychopharmacology and related fields in the following ways: promoting the interaction of a broad range of scientific disciplines of brain and behavior in order to advance the understanding of prevention and treatment of disease of the nervous system including psychiatric, neurological, behavioral and addictive disorders; encouraging scientists to enter research careers in fields related to these disorders and their treatment; and ensuring the dissemination of relevant scientific advances.

Caution Concerning Forward Looking Statements:

This press release may contain forward-looking statements made in reliance upon the safe harbor provisions of Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended.  Forward-looking statements include all statements that do not relate solely to historical or current facts, and can be identified by the use of words such as “may,” “will,” “expect,” “project,” “estimate,” “anticipate,” “plan,” “believe,” “potential,” “should,” “continue” or the negative versions of those words or other comparable words. Forward-looking statements are not guarantees of future actions or performance. These forward-looking statements are based on information currently available to KemPharm and its current plans or expectations and are subject to a number of uncertainties and risks that could significantly affect current plans. Risks concerning KemPharm’s business are described in detail in KemPharm’s Annual Report on Form 10-K for the year ended December 31, 2017, and KemPharm’s other Periodic and Current Reports filed with the Securities and Exchange Commission.  KemPharm is under no obligation to (and expressly disclaims any such obligation to) update or alter its forward-looking statements, whether as a result of new information, future events or otherwise.