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KemPharm Supports Recent FDA Recommendations for Hydrocodone-Containing Compounds and Abuse-Deterrent Opioids
Date:2/14/2013

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from Schedule III to Schedule II under the Controlled Substances Act, and on January 10, 2013, the FDA issued a draft guidance to assist pharmaceutical companies in the development of abuse-deterrent formulations of opioids.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
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SOURCE KemPharm, Inc.
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