FDA Sets PDUFA Date of March 2, 2021
CELEBRATION, Fla., May 19, 2020 (GLOBE NEWSWIRE) -- KemPharm, Inc. (KMPH), a specialty pharmaceutical company engaged in the discovery and development of proprietary prodrugs, today confirmed that the Company has received a filing communication from the U.S. Food and Drug Administration (FDA), commonly known as the “Day-74 Letter.” The Day-74 Letter stated that the New Drug Application (NDA) for KP415 is sufficiently complete to permit a substantive review by the FDA, and that the target goal date under the Prescription Drug User Fee Act (PDUFA) is March 2, 2021. In addition, the Day-74 Letter indicated that the FDA is not currently planning to hold an advisory committee to discuss the KP415 NDA.
“As expected, the FDA has set the PDUFA date for March 2, 2021, and we are pleased that the regulatory process is proceeding based on the promulgated timeframes,” said Travis C. Mickle, Ph.D., President and CEO of KemPharm. “This is another important regulatory milestone for KP415, and we look forward to working together with our partners at GPC and Corium to support the regulatory process and commercial preparation activities needed to facilitate a potential launch in the second half of 2021, if approved.”
KP415 is KemPharm’s investigational product candidate for the treatment of attention deficit hyperactivity disorder (ADHD), which contains serdexmethylphenidate (SDX), KemPharm’s prodrug of d-methylphenidate (d-MPH). In September 2019, KemPharm entered into the License Agreement with an affiliate of Gurnet Point Capital (GPC) for the exclusive worldwide rights to develop, manufacture and commercialize KemPharm’s product candidates containing SDX, including KemPharm’s ADHD product candidates, KP415 and KP484. GPC’s portfolio company, Corium, Inc., will lead all commercialization activities for 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, including earlier onset of action and longer duration of therapy, while avoiding unnecessary spikes in d-MPH concentrations that may be associated with adverse events. In addition, 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.
KemPharm is a specialty pharmaceutical company focused on the discovery and development of proprietary prodrugs to treat serious medical conditions through its proprietary LAT® (Ligand Activated Therapy) technology. KemPharm utilizes its proprietary LAT® technology to generate improved prodrug versions of FDA-approved drugs as well as to generate prodrug versions of existing compounds that may have applications for new disease indications. KemPharm’s prodrug product candidate pipeline is focused on the high need areas of attention deficit hyperactivity disorder, or ADHD, and stimulant use disorder. KemPharm’s co-lead clinical development candidates for the treatment of ADHD, KP415 and KP484, are both based on a prodrug of d-methylphenidate, but have differing duration/effect profiles. In addition, KemPharm has received FDA approval for APADAZ®, an immediate-release combination product containing benzhydrocodone, a prodrug of hydrocodone, and acetaminophen. For more information on KemPharm and its pipeline of prodrug product candidates visit www.kempharm.com or connect with us on Twitter, LinkedIn, Facebook and YouTube.
Caution Concerning Forward Looking Statements:
This press release may contain forward-looking statements made in reliance upon the safe harbor provisions of Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended. Forward-looking statements include all statements that do not relate solely to historical or current facts, including without limitation the Company’s proposed development and commercial timelines, and can be identified by the use of words such as “may,” “will,” “expect,” “project,” “estimate,” “anticipate,” “plan,” “believe,” “potential,” “should,” “continue” or the negative versions of those words or other comparable words. Forward-looking statements are not guarantees of future actions or performance. These forward-looking statements, including the potential FDA approval of the KP415 NDA, the potential commercial launch of KP415, and the potential clinical benefits of KP415 or any of our product candidates, are based on information currently available to KemPharm and its current plans or expectations and are subject to a number of uncertainties and risks that could significantly affect current plans. Risks concerning KemPharm’s business are described in detail in KemPharm’s Annual Report on Form 10-K for the year ended December 31, 2019, and KemPharm’s other Periodic and Current Reports filed with the Securities and Exchange Commission. KemPharm is under no obligation to (and expressly disclaims any such obligation to) update or alter its forward-looking statements, whether as a result of new information, future events or otherwise.