KemPharm's (KMPH) KP415 IND Accepted by U.S. FDA

October 11, 2016 7:31 AM EDT
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KemPharm, Inc. (Nasdaq: KMPH) announced that its Investigational New Drug (IND) application for KP415 has been accepted by the U.S. Food and Drug Administration (FDA). KP415, KemPharm’s co-lead product candidate, is an extended release (ER) d-threo-methylphenidate (d-MPH) prodrug for the treatment of attention deficit hyperactivity disorder (ADHD). KemPharm expects to commence and complete proof of concept human trials prior to the end of 2016, with additional human clinical trials initiating during the first half of 2017.

“We are very pleased that the FDA accepted our IND request for KP415, our co-lead product candidate, and expect to advance this program through proof-of-concept before year-end and into human clinical trials,” stated Travis C. Mickle, Ph.D., President and Chief Executive Officer of KemPharm. “Based on our estimates, in 2015, methylphenidate accounted for approximately 19.7 million prescriptions and $4.2 billion in sales in the ADHD market.”

“However, patent expiration in the ADHD space is eroding the revenues of branded products,” Mickle continued. “We believe KP415 offers the opportunity to address this market dynamic with a prodrug technology that, in pre-clinical studies, has demonstrated both extended release properties and a pharmacokinetic profile that could enable a more predictable therapy compared with currently available, immediate-release d-MPH products.”

KemPharm anticipates submitting a New Drug Application (NDA) submission for KP415 as early as 2018. In preclinical studies of KP415, KemPharm observed features that it believes could provide significant benefits when compared with other FDA-approved and widely prescribed methylphenidate products. Pharmacokinetic data from those preclinical studies suggest that the time to maximum plasma concentration of methylphenidate after oral administration of KP415 is approximately three times longer compared to immediate release methylphenidate. As a prodrug that requires metabolism, KP415 may be able to deliver d-MPH more consistently than the current formulation based approaches. This improved delivery may provide more consistent therapy.

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