KemPharm, Inc., a clinical stage biopharmaceutical company focused on the discovery and development of new, safer therapies to treat pain, has successfullly completed an End-of-Phase II meeting with the US 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 programmes 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 programme 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 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.