The company calls a Florida town called Celebration its home, and
KemPharm, Inc. (NASDAQ: KMPH) Friday had reason to celebrate.
The specialty pharmaceutical company engaged in the discovery and development of proprietary prodrugs, concluded Thursday a pre-New Drug Application ("NDA") meeting with the U.S. Food and Drug Administration ("FDA") for KP415, KemPharm’s investigational attention-deficit/hyperactivity disorder (ADHD) product candidate.
The meeting on Wednesday was aimed at discussing clinical, non-clinical and human abuse potential studies, as well as regulatory elements. Based on the feedback from the FDA, the Company believes its regulatory data package will be sufficient for submission, with acceptance of the filing subject to the FDA's review of the complete package.
According to CEO Travis Mickle,"We are pleased with the collaborative tone of our meeting with the FDA, and we now have a solid understanding of the Agency's requirements for our submission.”
KP415 is KemPharm’s prodrug product candidate being developed for the treatment of ADHD, and is designed to address unmet needs with the most prescribed methylphenidate ADHD treatments, including earlier onset of action and longer duration of therapy.
In addition, the results from the Human Abuses Potential program for the SDX component of KP415 suggest that the prodrug may have lower abuse potential than relevant d-MPH comparators.
In addition, KemPharm has received FDA approval for APADAZ®, an immediate-release combination product containing benzhydrocodone, a prodrug of hydrocodone, and acetaminophen.
Shares in KMPH gained two cents, or 1.2%, as the clock approached noon ET on Friday, to $1.71.
