KemPharm (KMPH) Announces Filing of KP415 IND as ADHD Treatment

September 19, 2016 7:04 AM EDT
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KemPharm, Inc. (Nasdaq: KMPH) announced that it has filed an Investigational New Drug (IND) application with the U.S. Food and Drug Administration (FDA) to begin human clinical trials of KP415, the Company’s prodrug, extended release (ER) d-threo-methylphenidate product candidate for the treatment of attention deficit hyperactivity disorder (ADHD).

In preclinical studies of KP415, KemPharm observed features that could provide significant benefits when compared with other FDA-approved and widely prescribed methylphenidate products. Pharmacokinetic data from those 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 (IR) methylphenidate. KemPharm believes this ER attribute of KP415’s molecular structure may allow for convenient, once-daily dosing

“We are very excited to have the opportunity to initiate clinical development of KP415, which we believe represents KemPharm’s highest value pipeline candidate,” stated Travis C. Mickle, Ph.D., President and Chief Executive Officer of KemPharm. “KP415 has demonstrated both extended release properties and a pharmacokinetic profile in pre-clinical studies that, if validated in the next phase of clinical trials, would lead to a more predictable therapy. This would be an important advancement for the ADHD market.”

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