Coralville-based biotech company KemPharm announced Wednesday that its first drug submitted to the U.S. Food and Drug Administration (FDA) has been granted priority review, and should be more closely examined by regulators by June.
The company's New Drug Application seeks review of KP201/APAP, an "immediate release" combination of the company's prodrug of hydrocodone, KP201, and acetaminophen, the active ingredient used in name-brand pain relievers such as Tylenol. Hydrocodone is an opioid and pain reliever for moderate to severe pain, according to the National Institute of Health. The drug can be habit-forming, and is sometimes compared to morphine or oxycodone due its potential for abuse.
KemPharm has requested Schedule III classification of the drug, which its developers said has "the reduced potential for abuse and the potential safety features attributable to lower exposure levels to hydrocodone for KP201/APAP as compared to other hydrocodone/APAP products," which are designated as Schedule II.
Travis C. Mickle, president and CEO of KemPharm, said in a news release that the drug's pending review marks a significant success for the company.
"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," Mr. Mickle said.
The FDA has set a target action date under the Prescription Drug User Fee Act of June 9.