KemPharm, Inc. announced that the U.S. Food and Drug Administration (FDA) has granted a fee waiver and has refunded the full user fee amount of $2,374,200 for its New Drug Application (NDA) filing for KP201/APAP, the Company’s investigational immediate release combination of its hydrocodone prodrug, KP201 (benzhydrocodone hydrochloride), and acetaminophen (APAP), which is currently under priority review by the FDA. The FDA has set a target action date under the Prescription Drug User Fee Act of June 9, 2016.
The fee waiver, which KemPharm requested in accordance with section 736(d)(1)(E) of the Federal Food, Drug and Cosmetic Act, is granted to a small business, as defined by the Small Business Administration, for the first human drug application submitted to the FDA for review.
KemPharm developed KP201/APAP using the Company’s proprietary Ligand-Activated Technology (LAT), which creates a new prodrug by chemically attaching one or more molecules, or ligands, to an FDA-approved parent drug. Once administered, human metabolic processes, such as those in the gastrointestinal tract, separate the ligand from the prodrug and release the active parent drug, which can then provide its therapeutic effect.
