KemPharm (KMPH) to Initiate Development of Oxymorphone Oral Prodrug KP746

December 30, 2015 8:34 AM EST

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KemPharm, Inc. (NASDAQ: KMPH) announced plans to initiate development of KP746, a recently identified oral prodrug of oxymorphone. Oxymorphone, marketed under the brand name Opana®, is a commonly prescribed medication for the management of pain in patients where an opioid anagelsic is appropriate. KP746 has the potential to be the first approved prodrug of oxymorphone.

Based on preclinical studies of KP746, KemPharm believes that the prodrug may offer enhanced bioavailability at typical therapeutic doses and abuse-deterrent features in comparison to standard oxymorphone. Specifically, based on preclinical studies, KemPharm believes KP746 may be highly tamper-resistant and may be stable under conditions that can potentially defeat many other abuse-deterrent technologies, suggesting greatly reduced intranasal bioavailability and minimal to no release of oxymorphone when administered intravenously.

KP746 applies KemPharm’s Ligand Activated Therapy (LAT) platform technology, adding to its pipeline of opioid prodrug product candidates, which includes KP201/APAP and KP201/IR (prodrugs of hydrocodone with and without acetaminophen), KP511/ER (a prodrug of hydromorphone), and KP606/IR (a prodrug of oxycodone). In addition, KemPharm is developing KP415, a prodrug of methylphenidate with controlled release (CR) features, for managing ADHD.

Travis C. Mickle, Ph.D., President and CEO of KemPharm, stated, “We are very pleased to introduce KP746 to our advancing pipeline of opioid prodrug candidates as we seek to enhance our clinical-stage product portfolio while progressing KP201/APAP through regulatory review and potential commercialization. Oxymorphone is a commonly prescribed opioid analgesic, which, while effective at treating the symptoms of pain, has been found to have the potential for abuse and misuse similar to other opioids. Like our other opioid prodrug candidates, KP746 has features that may deter tampering and abuse on the molecular level, potentially limiting opioid exposure when misused either intranasally, intravenously, orally, or when subjected to various physical and chemical manipulation techniques commonly used by opioid abusers.”

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