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KemPharm Receives “Fast Track” Designation for KP511, an Investigational Prodrug of Hydromorphone

CORALVILLE, Iowa, May 10, 2016 (GLOBE NEWSWIRE) -- KemPharm, Inc. (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...