FDA Approves First Prodrug of Hydrocodone/Acetaminophen for Acute Pain
In a press release issued last week, KemPharm, Inc., announced that the Food and Drug Administration (FDA) has approved its New Drug Application for Apadaz for the short-term management of acute pain severe enough to warrant an opioid analgesic and for which alternate treatments have been inadequate. Apadaz is an immediate release (IR) combination of the company’s prodrug, benzhydrocodone, and acetaminophen (APAP). Concurrently, according to the release, the US Drug Enforcement Administration announced intent to schedule Apadaz as a C-II product. Travis Mickle, PhD, President and CEO of KemPharm, said, “The approval of Apadaz…creates the opportunity to introduce what we believe is a differentiated product for the short-term management of acute pain. We are excited by the opportunity Apadaz offers to patients and for physicians who now have the option of prescribing a differentiated product.”
According to the company, Apadaz is unique among prescription opioids as it contains a prodrug that requires ingestion for activation. When taken, enzymes in the gastrointestinal tract cleave the ligand from the prodrug, releasing the parent drug (hydrocodone) which, in combination with acetaminophen provides therapeutic effect equivalent to currently approved IR hydrocodone/APAP combination products. Dr. Mickle further noted that “The Apadaz approval highlights the value potential that LAT (Ligand Activated Therapy) offers in the discovery and development of proprietary prodrugs that are designed to be differentiated versions of widely prescribed, currently approved drugs.”
Read a news release about the announcement.
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