KemPharm, Inc., a clinical-stage specialty pharmaceutical company, discovers and develops new proprietary prodrugs in the United States. Its advanced product candidate is KP201/APAP, which consists of KP201 prodrug of hydrocodone formulated in combination with acetaminophen (APAP). The company is also developing KP201/APAP as an immediate release (IR) product candidate for the treatment of acute pain, as well as engages in designing KP201/APAP with abuse-deterrent properties to address the epidemic of opioid abuse. The company is also involved in developing KP201/IR (APAP-free), an IR formulation of KP201 without APAP for the short-term management of acute pain; KP511/ER, a prodrug of hydromorphone for the management of pain; KP415, a prodrug of methylphenidate for the treatment of attention deficit hyperactivity disorders; KP606/IR, an IR abuse-deterrent opioid product for the management of moderate to severe pain; and KP746, a prodrug of oxymorphone for the management of moderate to severe pain. KemPharm, Inc. was founded in 2006 and is headquartered in Coralville, Iowa.
+10% this morning KemPharm Receives Clearance from FDA to Initiate Clinical Program for KP415, an Investigational Prodrug of D-Threo-Methylphenidate for the Treatment of ADHD CORALVILLE, Iowa, Oct. 11, 2016 (GLOBE NEWSWIRE) -- KemPharm, Inc. (KMPH), a clinical-stage specialty pharmaceutical company focused on the discovery and development of proprietary prodrugs, today announced that its Investigational New Drug (IND) application for KP415 has been accepted by the U.S. Food and Drug Administration (FDA). KP415, KemPharm’s co-lead product candidate, is an extended release (ER) d-threo-methylphenidate (d-MPH) prodrug for the treatment of attention deficit hyperactivity disorder (ADHD). KemPharm expects to commence and complete proof of concept human trials prior to the end of 2016, with additional human clinical trials initiating during the first half of 2017.
