KemPharm Completes Successful End-of-Phase 2 Meeting with FDA Clinical, Non-Clinical and CMC Development Programs on Track for Third Quarter NDA Submission
NORTH LIBERTY, Iowa, Nov. 1, 2013 /PRNewswire/ -- KemPharm, Inc., a clinical stage biopharmaceutical company focused on the discovery and development of new, safer therapies to treat pain, announced today the successful completion of an End-of-Phase 2 meeting with the Food and Drug Administration (FDA) for its lead pain candidate, KP201 (benzhydrocodone hydrochloride and acetaminophen). Based on the results of the meeting, KemPharm believes the completed and ongoing clinical, non-clinical and CMC development programs will allow for the submission of a New Drug Application (NDA) for KP201 in the third quarter of 2014.
During the meeting, representatives from the FDA reviewed KemPharm's current portfolio of data for KP201, including the recently completed bioequivalence and "steady-state" pivotal clinical studies. It was determined that the final data package, as proposed by KemPharm, would support a potential 505(b)(2) filing pathway without any additional efficacy, toxicology or safety data being required.
Travis C. Mickle, Ph.D., President and CEO of KemPharm, commented, "The positive feedback we received from the Agency re-affirms prior discussions related to our clinical and non-clinical program for KP201 and our plan to pursue an NDA via the 505(b)(2) pathway. Based on their advice, we are extremely confident in our plan to submit an NDA by the third quarter of 2014 and seek potential approval of the first novel pain therapy of the morphine class to be developed in a number of years with an officially recognized new chemical structure."
KP201 is in development for the treatment of acute moderate to moderately severe pain. Composed of hydrocodone chemically bound to a ligand, KP201 offers unique physicochemical and pharmacological attributes that may deliver additional patient benefits, including reduced potential for abuse and reduction or elimination of opioid-induced constipation (OIC).
Mickle continued, "The next clinical milestone for KP201 will be the completion of oral and intranasal abuse liability studies in the first quarter of 2014. These studies will be important indicators of KP201's unique abuse-deterrent capabilities, which we believe are unlike any prescription opioid on the market or in development."
KemPharm is abiopharmaceutical company focused on the discovery and development of new chemical entities (NCEs) to treat serious medical conditions through its proprietary and broadly applicable Ligand Activated Therapy (LAT) approach. The company utilizes its LAT technology to generate improved prodrug versions of FDA approved drugs in the high needs areas of pain, ADHD and other CNS diseases. KemPharm's lead clinical candidate, KP201, is in development for the treatment of acute, moderate to moderately severe pain with a new drug application (NDA) expected to be filed in the third quarter of 2014. Composed of hydrocodone chemically bound to a ligand, KP201 offers unique physicochemical and pharmacological attributes that may deliver additional patient benefits, including reduced potential for abuse and reduction or elimination of opioid-induced constipation (OIC). KemPharm's pipeline is also highlighted by KP511, its hydromorphone prodrug for pain, KP606, its oxycodone prodrug for pain, and KP415, a prodrug of methylphenidate for the treatment of ADHD. For more information on KemPharm, please visit the company's website at www.kempharm.com
SOURCE KemPharm, Inc.