KemPharm, Inc. Completes Pre-IND Meeting with FDA for NME Prodrug of Hydromorphone, KP511

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Dec 09, 2014, 08:02 ET

CORALVILLE, Iowa, Dec. 9, 2014 /PRNewswire/ -- KemPharm, Inc., a clinical-stage specialty pharmaceutical company engaged in the discovery and development of proprietary new molecular entity (NME) prodrugs, announced today that it had a pre-investigational new drug (pre-IND) meeting with the U.S. Food and Drug Administration (FDA) concerning KemPharm's NME prodrug of hydromorphone, KP511. The meeting, which occurred on December 4, 2014, was held with the FDA to obtain input on the pre-clinical and clinical plan for KP511.

KP511, which is being developed for the treatment of moderate to severe pain, combines hydromorphone with one or more ligands and can be formulated in both immediate release (IR) and extended release (ER) dosage forms. The NME prodrug is designed not to release its hydromorphone component until it is metabolized in the gastrointestinal tract following oral administration. As such, KemPharm believes KP511 is highly tamper-resistant and is stable under conditions that can potentially defeat many formulation-based abuse-deterrent technologies.

Travis C. Mickle, Ph.D., President and CEO of KemPharm, commented, "We are very pleased to have completed this important milestone as the pre-IND meeting with the FDA has given us a path to progress KP511 through the clinical development process."

KemPharm was recently issued a composition-of-matter patent from the United States Patent and Trademark Office for KP511, which will expire, after utilizing all appropriate patent term adjustments but excluding possible patent term extensions, in 2032.

About KemPharm

KemPharm is a specialty company focused on the discovery and development of NME prodrugs to treat serious medical conditions through its Ligand Activated Therapy (LAT) platform technology. KemPharmutilizes its LAT platform technology to generate improved prodrug versions of FDA-approved drugs in the high needs areas of pain, ADHD and other CNS disorders. For more information on KemPharm, please visit www.kempharm.com.

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SOURCE KemPharm, Inc.