The application covers composition of matter for KP415, the company’s NME prodrug of methylphenidate.
KP415 is designed to be a controlled release (CR), abuse-deterrent methylphenidate product and is being developed to treat attention deficit hyperactivity disorder (ADHD).
KemPharm president and CEO Travis Mickle said: "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."
In preclinical trials of KP415, the company has observed features that could provide significant benefits to patients, physicians, and society when compared to other FDA-approved and widely prescribed methylphenidate products.
KP415 uses the company’s LAT platform technology to allow abuse-deterrent properties at the molecular level similar to KP201, its most advanced product candidate, which is an NME prodrug of hydrocodone.
In addition, pharmacokinetic data from preclinical studies suggest that the time to maximum plasma concentration of methylphenidate after oral administration of KP415 is about three times longer compared to the currently marketed immediate release (IR) methylphenidate.