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Shares of KemPharm Inc (NASDAQ: KMPH), a clinical-stage specialty pharmaceutical company, surged higher by more than 17 percent on Wednesday after the company confirmed that the U.S. Food and Drug Administration granted priority review for its KP201/APAP drug.
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KemPharm's KP201/APAP is an investigational drug candidate for the short-term management of acute pain. The FDA has also set a target action date under the Prescription Drug User Fee Act (PDUFA) of June 9, 2016.
"We believe this milestone brings us one step closer to providing prescribers and patients with a new acute pain treatment option that may deter certain common methods of abuse while providing the same pharmacokinetic and therapeutic effect as currently available immediate-release hydrocodone/APAP medications," said Travis C. Mickle, Ph.D., President and CEO of KemPharm. "Equally important, we are pleased that the FDA has agreed to a priority review of the NDA with a target PDUFA date of June 9th, which is sooner than was previously anticipated. We look forward to working closely with the agency over the coming months as it considers this potential new option for physicians who are treating patients with acute pain."