Product Portfolio: ADHD
KP415 is a NME prodrug of methylphenidate, which KemPharm is developing for the treatment of ADHD. The ADHD market is largely served by the stimulant products methylphenidate and amphetamine, and KP415 is designed to be a controlled release (CR) abuse-deterrent methylphenidate product.
KemPharm currently expects to initiate and complete of pivotal studies of KP415 in 2017, leading to a potential New Drug Application (NDA) for KP415 as early as 2018. KemPharm plans to seek approval of KP415 under the 505(b)(2) NDA pathway.
Key Product Features of KP415
Based on our preclinical data, KemPharm believes KP415, if approved by the FDA, may have valuable product features and provide significant benefits to patients, physicians, and society when compared to other FDA-approved and widely prescribed methylphenidate products:
- Molecular-based abuse-deterrent technology. KP415 utilizes its LAT platform technology to create its abuse-deterrent properties at the molecular level, and the company believes it will have abuse-deterrent characteristics similar to KP201/APAP.
- Once-daily dosing. Pharmacokinetic data from preclinical studies show that the time to maximum plasma concentration of methylphenidate after oral administration of KP415 is approximately three times longer than that after oral administration of currently marketed IR methylphenidate. KemPharm believes this inherent CR attribute of KP415’s molecular structure may allow for convenient, once-daily dosing.
- Amenable to patient-friendly formulations. Although KemPharm believes KP415 possesses abuse-deterrent properties at the molecular level similar to KP201, its preclinical data shows that KP415 is highly water soluble, and we believe it could ultimately be used in a variety of patient-friendly dosage forms such as oral thin film, orally dissolving tablets, chewable tablets and liquids as a means of increasing patient convenience and compliance.