KemPharm Presents Data from Intranasal and Intravenous Human Abuse Potential Trials of KP415 Prodrug at the American Academy of Child & Adolescent Psychiatry Meeting

CORALVILLE, Iowa, Oct. 24, 2018 (GLOBE NEWSWIRE) -- KemPharm, Inc. (NASDAQ:KMPH), a specialty pharmaceutical company focused on the discovery and development of proprietary prodrugs, today announced the presentation of posters from two human abuse potential (HAP) trials for its KP415 prodrug candidate to treat attention deficit hyperactivity disorder (ADHD).  The posters will be presented today at the 65^th Annual American Academy of Child and Adolescent Psychiatry (AACAP) Meeting in Seattle, Washington.

The first poster, titled, “Human Abuse Potential of Intravenous Serdexmethylphenidate (SDX), a Novel Prodrug of d-Methylphenidate, in Recreational Stimulant Abusers,” reported data from the intravenous (IV) HAP clinical trial of SDX, KemPharm’s novel prodrug of d-methylphenidate (d-MPH) and the major active pharmaceutical ingredient (API) in KP415, an investigational product for the treatment of ADHD. The results of this 30-subject trial (KP415.A03) demonstrated that IV administration of SDX yielded minimal exposure to d-MPH and was statistically similar to placebo on multiple standard abuse-related endpoints, suggesting that SDX is unlikely to be attractive for IV abuse.

The second poster, titled, “Dose-finding Study of Abuse-Related Effects of Intranasal d-Methylphenidate in Recreational Stimulant Abusers,” reported results from a study designed to identify the optimal intranasal (IN) dose of d-MPH that was subsequently used as the active comparator in a study (KP415.A02) evaluating the IN-abuse potential of SDX. The results of this six-subject study demonstrated that 40 mg of d-MPH produced an optimal balance of Drug Liking/Good Effects and Bad Effects in recreational stimulant abusers, and thus was selected as the positive control in the IN HAP study of SDX.

“Results from the overall KP415 HAP program suggest that our KP415 prodrug, or serdexmethylphenidate, has lower abuse potential than relevant d-methylphenidate comparators when misused intranasally, intravenously, or orally at high doses,” said Travis Mickle, Ph.D., President and Chief Executive Officer of KemPharm. “The posters presented at AACAP with key data from the KP415 HAP program, combined with the feedback from key opinion leaders (KOLs) provided at our recent Investor Event highlight the pre-market commercial perceptions that we believe will be valuable to a potential partner. We appreciate the opportunity to present these findings to the attendees at AACAP, many of whom are at the forefront of ADHD research and patient care, as we prepare to submit our New Drug Application with the FDA as early as Q1 2019.”

Both studies were sponsored by KemPharm.

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, and its co-lead clinical development candidates are KP415 and KP484, both based on a prodrug of d-methylphenidate, but with differing extended-release/effect profiles, are 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.

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. These forward-looking statements include statements regarding the expected features and characteristics of KemPharm’s product candidates, including KP415, the partnering process for KP415 and KP484, as well as the expected timing of the completion of any clinical trials or studies related to KP415 and the expected timing of the NDA submission for KP415. 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 Actual results and performance could differ materially from those projected in the forward-looking statements as a result of many factors, including the risks and uncertainties associated with: KemPharm's financial resources and whether they will be sufficient to meet KemPharm's business objectives and operational requirements; results of earlier studies and trials may not be predictive of future clinical trial results; the protection and market exclusivity provided by KemPharm's intellectual property; risks related to the drug discovery and the regulatory approval process; the impact of competitive products and technological changes; and the FDA approval process under the Section 505(b)(2) regulatory pathway, including without limitation any timelines for related approval. Risks concerning KemPharm’s business are described in detail in KemPharm’s Quarterly Report on Form 10-Q for the quarter ended June 30, 2018, filed with the Securities and Exchange Commission (SEC) on August 10, 2018, and KemPharm’s other Periodic and Current Reports filed with the SEC.  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.