KemPharm, Inc., a clinical stage biopharmaceutical company focused on the discovery and development of new, safer therapies to treat pain, announced today a successful Type B meeting with the Food and Drug Administration (FDA) for its lead pain candidate, KP201. The meeting was held to obtain input from the Agency in regard to the remaining clinical and non-clinical program required for submission of a new drug application (NDA) for KP201.
KemPharm presented to the FDA its clinical and non-clinical data that have been completed to date along with its remaining proposed studies in support of a potential 505(b)(2) filing pathway.
"Based on the discussion KemPharm had with the Agency, we are confident that KP201 will be able to proceed under a 505(b)(2) filing which will allow for a greatly shortened development timeline compared to most new chemical entities," stated Dr. Sven Guenther, Vice President of Research. "Additionally, the remaining studies, both clinical and non-clinical, along with manufacturing, represent a fairly low development risk."
KP201 is in development for the treatment of acute moderate to moderately severe pain with a new drug application on target to be filed in Q2 2014.