KemPharm, Inc. Receives Notice of Allowance for NME Prodrug of Methylphenidate, KP415

CORALVILLE, Iowa, Dec. 5, 2014 /PRNewswire/ -- KemPharm, Inc., a clinical-stage specialty pharmaceutical company engaged in the discovery and development of proprietary new molecular entity (NME) prodrugs, announced today that it has received a Notice of Allowance from the United States Patent and Trademark Office (USPTO) for its patent application titled, "Methylphenidate-oxoacid conjugates, processes of making and using the same."  The patent application covers composition of matter for KP415, KemPharm's NME prodrug of methylphenidate.

KemPharm is developing KP415 for the treatment of attention deficit hyperactivity disorder (ADHD).  KP415 is designed to be a controlled release (CR), abuse-deterrent methylphenidate product.

In preclinical studies of KP415, KemPharm has observed features that could provide significant benefits to patients, physicians, and society when compared to other FDA-approved and widely prescribed methylphenidate products.  Namely, KP415 utilizes KemPharm's LAT platform technology to enable abuse-deterrent properties at the molecular level similar to KP201, KemPharm's most advanced product candidate, which is an NME prodrug of hydrocodone. 

Additionally, pharmacokinetic data from preclinical studies suggest that the time to maximum plasma concentration of methylphenidate after oral administration of KP415 is approximately three times longer compared to currently marketed immediate release (IR) methylphenidate.  KemPharm believes this inherent CR attribute of KP415's molecular structure may allow for convenient, once-daily dosing.

Travis C. Mickle, Ph.D., President and CEO of KemPharm, commented, "The Notice of Allowance for KP415 is a significant development for KemPharm as it showcases an opportunity for KemPharm to expand its pipeline beyond the pain market and into ADHD, which, like pain, faces similar issues of abuse and misuse of currently marketed drugs. We believe the ADHD market would be receptive to a new product in the form of a prodrug that has abuse-deterrent features and a more consistent controlled release drug delivery mechanism, potentially providing a preferred treatment option in this large market segment."

About KemPharm

KemPharm is aspecialty pharmaceutical company focused on the discovery and development of NME prodrugs to treat serious medical conditions through its Ligand Activated Therapy (LAT) platform technology.  KemPharmutilizes its LAT platform technology to generate improved prodrug versions of FDA-approved drugs in the high needs areas of pain, ADHD and other CNS disorders.  For more information on KemPharm, please visit www.kempharm.com.

SOURCE KemPharm, Inc.

Related Links

http://www.kempharm.com