KemPharm (NASDAQ:KMPH) met with the FDA to discuss the NDA for KP415, its attention deficit hyperactivity disorder (ADHD) drug candidate.
KP415 consists KemPharm’s prodrug of d-methylphenidate (d-MPH), co-formulated with immediate-release d-MPH. KP415 is designed to have an earlier onset of action and longer duration compared with MPH. KemPharm states that KP415 has an onset of action at 30 minutes and a duration of effect of 13 hours.
Based on the meeting, KemPharm believes its regulatory data package will be sufficient for submission, and noted that the FDA would not require any additional efficacy study or data assess KP415’s efficacy in treating ADHD.
“Based on feedback received during this meeting and from previous correspondences, we are confident in moving forward with our NDA package for KP415, which is on track for submission in late Q2 or early Q3 2019, Travis Mickle, KemPharm’s president and CEO, said in a statement.”