March 02, 2020: KemPharm announced that it has submitted a New Drug Application (NDA) under Section 505(b)(2) of the Federal Food, Drug and Cosmetic Act for its investigational product candidate, KP415, to the U.S.FDA.
KP415 is KemPharm’s product candidate for the treatment of attention deficit hyperactivity disorder (ADHD) which contains serdexmethylphenidate (SDX), KemPharm’s prodrug of the d-methylphenidate (d-MPH).
At first, the FDA will review the data package and, if deemed to be complete, will issue formal notice of the acceptance of the submission, a process which usually takes sixty (60) days from the date of submission. Since KP415 contains SDX, which is a new molecular entity (NME), the FDA review guidance for the NMEs is ten (10) months from the date of acceptance, which could lead to a potential action (PDUFA) date in March 2021.
“Submission of the KP415 NDA is a significant milestone for KemPharm as we seek FDA approval for our first ADHD product candidate based on our proprietary LAT™ prodrug technology,” said Travis C. Mickle, Ph.D., President and CEO of KemPharm. “We believe the data package submitted with the NDA supports our conclusion that KP415 is effective in treating ADHD, has an onset of action at 30 minutes, has a duration of effect of 13 hours, and avoids unnecessary spikes in d-MPH concentrations that may be associated with adverse events. We also believe that the SDX component of KP415 may have lower abuse potential than relevant d-MPH comparators.”
The KP415 NDA filing was prepared by KemPharm in collaboration with the Gurnet Point Capital (GPC). KemPharm entered into a strategic licensing agreement in Sep 2019 with an affiliate of GPC, for the exclusive worldwide rights to develop, manufacture and, if approved, commercialize KemPharm’s product candidates containing SDX, including KemPharm’s ADHD product candidates, KP415 and KP484. This license agreement provides that a regulatory milestone payment will be payable to KemPharm thirty (30) days following FDA acceptance of the KP415 NDA.
“We look forward to working with the FDA as they complete their review of the KP415 NDA,” Dr. Mickle concluded. “In addition, our work continues with GPC’s commercial team as we now focus on preparing for the potential launch of KP415 in the U.S.”
About KP415: KP415 consists of SDX co-formulated with immediate-release d-MPH and is designed to address unmet needs with the most widely-prescribed methylphenidate ADHD treatments that includes earlier onset of the action and longer duration of therapy, while avoiding unnecessary spikes in d-MPH concentrations that may be associated with adverse events. Additionally, results from the various Human Abuse Potential trials for the SDX component of KP415 suggest that the prodrug alone may have lower abuse potential than relevant d-MPH comparators.
https://fda.einnews.com/pr_news/511007171/kempharm-submits-kp415-nda-to-the-fda-for-the-treatment-of-adhd
