KemPharm, Inc. Supports Recent FDA Recommendations for Hydrocodone-Containing Compounds and Abuse-Deterrent Opioids

NORTH LIBERTY, Iowa, Feb. 14, 2013 /PRNewswire/ -- KemPharm, Inc., a clinical stage biopharmaceutical company focused on the discovery and development of new, safer therapies to treat pain, offered its support for the recent Food and Drug Administration (FDA) recommendations to curtail the potential abuse of opioid-based therapeutics.

In two separate actions, on January 25, 2013, the FDA's Drug Safety and Risk Management Advisory Committee (DSaRM) voted in favor of reclassifying hydrocodone combination products from Schedule III to Schedule II under the Controlled Substances Act, and on January 10, 2013, the FDA issued a draft guidance to assist pharmaceutical companies in the development of abuse-deterrent formulations of opioids.

Travis C. Mickle, Ph.D., president and CEO of KemPharm, commented, "Opioid-based therapeutics manage pain very well, but safe-guards and technological enhancements are needed to mitigate a clear abuse risk. The recent FDA actions clearly speak to this issue, and KemPharm welcomes the 'call-to-arms' as we advance the development of our lead compound, KP201 (benzhydrocodone)."

Mickle continued, "The more stringent hydrocodone classification and the opioid abuse-deterrent development guidelines will undoubtedly serve to focus our industry, but advances in technology will be the ultimate factor in effecting positive change. This is KemPharm's rationale for developing KP201. Benzhydrocodone, which is chemically different from hydrocodone, has demonstrated the potential to reduce drug abuse and diversion as well as prevent opioid-induced constipation (OIC), while maintaining the same pain relieving effects of current market leading drugs."

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 Q2 2014. Recently assigned the nonproprietary name, "benzhydrocodone," by the United States Adopted Name (USAN) Council, KP201 represents the first novel pain therapy of the morphine class to be developed in a number of years with an officially recognized new chemical structure.

About KP201
KemPharm's most advanced opioid-based drug candidate, KP201, is composed of hydrocodone chemically bound to a ligand. The Company previously reported positive Phase 1 clinical data, which confirmed that KP201 is metabolized in man as predicted, releasing hydrocodone into the bloodstream at amounts equivalent to the reference listed drug, Norco^®. This data supports a 505(b)(2) regulatory pathway for KP201 in combination with acetaminophen.

KP201 has 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). Importantly, intact KP201 was not detected in systemic circulation, suggesting that minimal additional studies could be justified to determine the impact of KP201 exposure in the body.

KemPharm has worked diligently with its manufacturing partner, Johnson Matthey, to successfully and efficiently scale up KP201 active pharmaceutical ingredient (API) in anticipation of a commercial launch. KP201 is on track for an NDA submission to the FDA in 2014. KemPharm is actively seeking a strategic development partner with the expertise to take KP201 through regulatory review and commercialization.

About KemPharm
KemPharm is focused on the discovery and development of NCEs to treat serious medical conditions through its proprietary and broadly applicable LAT prodrug approach. KemPharm utilizes its LAT prodrug technology to generate improved versions of FDA approved drugs. KemPharm's business strategy includes seeking strategic development partners following rapid clinical proof-of-concept demonstration in a Phase 1 trial. KemPharm also plans to explore discovery stage alliances with industry leaders, leveraging its prodrug know-how and LAT technology. KemPharm is primarily focused on developing candidates for pain and other central nervous system disorders. www.kempharm.com

SOURCE KemPharm, Inc.