CORALVILLE, Iowa, May 10, 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 KP511, KemPharm’s prodrug of hydromorphone, has been granted “Fast Track” designation by the U.S. Food and Drug Administration (FDA). KP511 is being developed as an abuse-deterrent, extended-release (ER) prodrug for the management of pain severe enough to require daily, around-the-clock, long-term opioid treatment and for which alternative treatments are inadequate (KP511/ER). KemPharm initiated human clinical trials of KP511 in the second quarter of 2016.
“The decision by the FDA to designate KP511 for Fast Track review is a key milestone in the advancement of this program,” stated Travis C. Mickle, Ph.D., President and Chief Executive Officer of KemPharm. “As disclosed previously, we are planning to develop KP511 as an extended-release prodrug product candidate that could offer the potential to deter certain common methods of abuse while providing the same pharmacokinetic and therapeutic effect as existing hydromorphone products when taken as intended.”
KemPharm plans to seek approval of KP511/ER under Section 505(b)(2) of the Federal Food, Drug and Cosmetic Act with an anticipated New Drug Application (NDA) submission as early as 2018. KP511 utilizes KemPharm’s Ligand Activated Therapy (LAT) platform technology to create potential abuse-deterrent properties at the molecular level. KemPharm believes that this proprietary design offers the potential to restrict the release of the active hydromorphone component until the prodrug is metabolized following oral administration. KP511/ER is designed to be bioequivalent to currently available ER hydromorphone products.
About Fast Track Designation
Fast Track is a process designed to facilitate the development, and expedite the review of drug candidates 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 candidate's development plan and ensure collection of appropriate data needed to support approval
- More frequent written communication from FDA about such things as the design of the proposed clinical trials and use of biomarkers
- 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 New Drug Application (NDA) for review by FDA, rather than waiting until every section of the NDA is completed before the entire application can be reviewed.
More information about Fast Track status can be found via the following URL: http://www.fda.gov/ForPatients/Approvals/Fast/ucm405399.htm
KemPharm is a clinical-stage specialty pharmaceutical company focused on the discovery and development of proprietary prodrugs to treat serious medical conditions through its 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 CNS disorders.
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 and characteristics of KP511 and the timelines surrounding potential clinical trials for KP511 and the submission of an NDA for KP511/ER. 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 under the Section 505(b)(2) regulatory pathway, 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 Annual Report on Form 10-K for the fiscal year ended December 31, 2015, 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.
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