KP201/IR could be the first single entity (APAP-free), IR hydrocodone product for pain analgesia with abuse-deterrent properties
CORALVILLE, Iowa, Dec. 20, 2016 (GLOBE NEWSWIRE) -- KemPharm, Inc. (NASDAQ:KMPH), a clinical-stage specialty pharmaceutical company focused on the discovery and development of proprietary prodrugs, today announced that its Investigational New Drug application for KP201/IR has been granted “Fast Track” designation by the U.S. Food and Drug Administration (FDA). KP201/IR, KemPharm’s co-lead product candidate, is a single-entity benzhydrocodone HCl immediate release abuse-deterrent prodrug for the treatment of acute pain. KemPharm expects to initiate human clinical trials of KP201/IR in the first half of 2017.
“We are very pleased that the FDA has granted KP201/IR ‘Fast Track’ designation. This designation will help expedite the development and review of KP201/IR and provides us with the opportunity to have more frequent interactions with the Agency and a potential ‘rolling review’ of our application prior to submission of the complete New Drug Application (NDA) for KP201/IR,” said Travis Mickle, Ph.D., President and Chief Executive Officer of KemPharm. “As previously announced, we intend to initiate human clinical trials of KP201/IR in the first half of 2017 and remain on target for a potential submission in 2018 of the KP201/IR NDA.”
KP201/IR has the potential to reach the market as the first abuse-deterrent IR hydrocodone product, as well as the first IR hydrocodone-related product without acetaminophen (APAP). KemPharm believes KP201/IR is well-positioned to take advantage of data generated from the Apadaz™ development program, including data from the KP201.A03 study, which compared hydrocodone exposure following insufflation of benzhydrocodone HCl (KP201) vs. hydrocodone bitartrate. KemPharm believes that the data observed in the KP201.A03 study, if replicated in a full human abuse potential study, may align with the FDA Division of Anesthesia, Analgesia, and Addiction Products criteria for achieving abuse-deterrent product labeling.
About Fast Track Designation
Fast track is a process designed to facilitate the development, and expedite the review of drugs to treat serious conditions and fill an unmet medical need. The purpose is to get important new drugs to the patient earlier.
A drug that receives Fast Track designation is eligible for some or all of the following:
- More frequent meetings with FDA to discuss the drug's development plan and ensure collection of appropriate data needed to support drug approval
- Eligibility for Accelerated Approval and Priority Review, if relevant criteria are met
- Rolling Review, which means that a drug company can submit completed sections of its NDA for review by the FDA, rather than waiting until every section of the NDA is completed before the entire application can be reviewed.
KemPharm is a clinical-stage specialty pharmaceutical company focused on the discovery and development of proprietary prodrugs to treat serious medical conditions through its Ligand Activated Therapy (LAT) platform technology. KemPharm utilizes its LAT platform technology to generate improved prodrug versions of FDA-approved drugs in the high need areas of pain, ADHD and other central nervous system (CNS) disorders. KemPharm’s co-lead clinical development candidates are KP415, an extended-release (ER) prodrug of methylphenidate for the treatment of attention deficit hyperactivity disorder (ADHD), and KP201/IR, an acetaminophen (APAP)-free formulation of the company’s immediate release (IR) abuse deterrent hydrocodone product, KP201. For more information on KemPharm and its pipeline of prodrug product candidates visit www.kempharm.com.
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, 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. These forward-looking statements include statements regarding the expected features, characteristics, development timeline and potential submission of an NDA for KP201/IR. These forward-looking statements are not guarantees of future actions or performance. These forward-looking statements 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. Actual results and performance could differ materially from those projected in the forward-looking statements as a result of many factors, including, without limitation, the risks and uncertainties associated with: KemPharm's financial resources and whether they will be sufficient to meet KemPharm's business objectives and operational requirements; results of earlier studies and trials may not be predictive of future clinical trial results; the protection and market exclusivity provided by KemPharm's intellectual property; risks related to the drug discovery and the regulatory approval process; the impact of competitive products and technological changes; and the FDA approval process, including without limitation any timelines for related approval. KemPharm's forward-looking statements also involve assumptions that, if they prove incorrect, would cause its results to differ materially from those expressed or implied by such forward-looking statements. These and other risks concerning KemPharm’s business are described in additional detail in KemPharm's Quarterly Report on Form 10-Q for the quarter ended September 30, 2016, 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.
Jason Rando / Joshua Drumm, Ph.D.
Tiberend Strategic Advisors, Inc.
212-375-2665 / 2664
Daniel L. Cohen
Executive VP, Government and Public Relations