Product Portfolio: ADHD
KP415 is a NME prodrug of d-threo-methylphenidate (d-MPH), 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 an extended release (ER) d-MPH prodrug product candidate designed for the treatment of ADHD with patients that could benefit from both earlier onset as well as better total duration of effect.
KemPharm currently expects to initiate a pivotal efficacy trial of KP415, as well as a human abuse liability (HAL) study, in the second half of 2017, leading to a potential New Drug Application (NDA) for KP415 as soon as late 2018.
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 ER 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.
KP484 is KemPharm’s prodrug product candidate for a super-extended release (SER) d-MPH being designed for the treatment of ADHD in patients that respond best when a long duration of therapy beyond both KP415 and all current methylphenidate treatments is required. The therapeutic application was developed during a data analysis of the KP415 Phase 1 study, in which KemPharm observed that the prodrug molecule demonstrated an ability to produce a longer duration release of d-MPH relative to comparator products available on the market today.
KemPharm anticipates filing an Investigational New Drug (IND) application for KP484 as early as the third quarter of 2017. KemPharm expects to leverage data from certain clinical and nonclinical trials of KP415 to expedite the development of KP484. As a result, KemPharm expects to file an NDA for KP484 as soon as 2019.