KemPharm, a clinical-stage specialty pharmaceutical company focused on the discovery and development of proprietary prodrugs, announced preliminary results of KP415.109, a phase I trial designed to assess the relative pharmacokinetics (PK) of three different formulations of KP415 vs. a methylphenidate-containing comparator product (Concerta) at both single and multiple dose conditions.  KP415 is KemPharm’s co-lead ADHD product candidate.

“We are very pleased to report that our proposed co-formulation of our proprietary extended release (ER) KP415 d-methylphenidate (d-MPH) prodrug together with immediate release (IR) d-MPH demonstrated expected PK parameters in this phase I trial and is now being readied for further development in a safety and efficacy clinical trial later this year,” said Travis C. Mickle, Ph.D., president and chief executive officer of KemPharm.  “The trial demonstrated the expected early peak exposure due to the IR d-MPH component of the co-formulation, which was followed by sustained exposure to d-MPH from the ER KP415 prodrug over the course of the day, leading us to believe that our product candidate may have a longer total duration than current methylphenidate-based products.  Steady state exposure was reached after a few days with a negligible accumulation of the prodrug and sustained a duration similar that of Concerta after the 12-hour time point.”

“There is a clear need for an extended-release methylphenidate product, with the potential benefit of early onset and longer total duration, as a treatment option for patients,” said Ann Childress, M.D., an attention deficit hyperactivity disorder (ADHD) expert, and President of the Center for Psychiatry and Behavioral Medicine.  “Many patients prefer methylphenidate, but currently must take multiple doses of existing methylphenidate products. That means multiple prescriptions, multiple copays and the inconvenience of multiple daily doses. I am thrilled to see KP415 advance in development."

“Given that this phase I study performed as anticipated, we remain on schedule to begin the single pivotal efficacy clinical trial of KP415 prior to the end of this year,” added Mickle.  “Assuming the results of the pivotal trial are positive, we anticipate submitting a New Drug Application (NDA) with the FDA prior to the end of 2018.  We are excited for the potential KP415 now has highlighted for us.”