CELEBRATION, Fla., Dec. 02, 2020 (GLOBE NEWSWIRE) -- KemPharm, Inc. (OTCQB: KMPH), a specialty pharmaceutical company focused on the discovery and development of proprietary prodrugs, today announced that the Company participated in a late-cycle communication meeting on December 1, 2020, with the U.S. Food and Drug Administration (FDA, or the Agency) regarding the ongoing review of the New Drug Application (NDA) for KP415, KemPharm’s investigational product candidate for the treatment of attention deficit hyperactivity disorder (ADHD). In the meeting, the FDA did not raise any substantive issues related to KP415’s safety and efficacy at this point in their review of the KP415 NDA. In addition, the FDA re-affirmed the PDUFA date for the KP415 NDA is March 2, 2021.
KP415 is KemPharm’s investigational product candidate for the treatment of ADHD. KP415 consists of serdexmethylphenidate (SDX), KemPharm’s prodrug of d-methylphenidate (d-MPH), co-formulated with immediate-release d-MPH. KP415 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.
“The late-cycle review meeting with the FDA continued a series of productive meetings with the Agency, and sets the stage for the next phase of the NDA review process, including the potential for confidential discussions of the KP415 product label,” said Travis Mickle, Ph.D., President and CEO of KemPharm. “With approximately three months until the KP415 PDUFA date, we remain optimistic about the potential outcome and, accordingly, have been working closely with Corium to plan for the potential commercialization of KP415, if approved. This topic will be a primary focus for this morning’s ‘KP415 Market Opportunity and Commercialization Strategy’ webcast.”
KP415 Market Opportunity and Commercialization Strategy
Wednesday, December 2, 2020
10:00 AM (ET)
Audio webcast with slide presentation
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 timing of the PDUFA date and potential FDA approval of the KP415 NDA, the potential commercial launch of KP415, or the potential clinical benefits of KP415 or any of the Company’s 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, KemPharm’s Quarterly Report on Form 10-Q for the quarter ended September 30, 2020, 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.