Specialty pharmaceutical company KemPharm has moved a step closer to submitting a new drug application for KP415, its prodrug candidate designed for the treatment of Attention Deficit Hyperactivity Disorder (ADHD), the company announced today.
The Coralville-based company completed its End-of-Phase 2 meeting with the Food and Drug Administration (FDA), allowing the drug to move into a required pivotal efficacy trial by the end of this year. That could lead to a potential New Drug Application (NDA) submission by the company by the end of 2018.
The pivotal trial is required to provide evidence that HP415 can support a label indication of both early onset of action and extended duration, "both of which are unmet needs with current methylphenidate products," KemPharm President and CEO Travis Mickle stated in a press release.
The FDA recently completed a review of KemPharm's Investigational New Drug (IND) application for KP484, a super-extended release prodrug for the treatment of ADHD, which will allow it to proceed to trials.
"This advancement, coupled with the ongoing development of KP415, our lead ADHD prodrug candidate, positions KemPharm to potentially have two late-stage product candidates designed to address important unmet treatment needs in ADHD," Mr. Mickle said.
KemPharm last week reported a net loss of $10 million in the third quarter, or 68 cents per share. That compared to a loss of $13.4 million, or 92 cents a share, in the same period last year.