The Food and Drug Administration (FDA) has approved Apadaz (benzhydrocodone and acetaminophen; KemPharm) for the short-term (≤14 days) management of acute pain severe enough to require an opioid analgesic and for which alternative treatments are inadequate.
Apadaz is an immediate-release combination of benzhydrocodone, a prodrug of hydrocodone, and acetaminophen (APAP).
Benzhydrocodone is chemically inert, however, once ingested, enzymes in the gastrointestinal tract cleave the ligand from the prodrug and release hydrocodone, producing a therapeutic effect.
“In addition to today’s approval, the US Drug Enforcement Administration (DEA) has indicated that it is their intent to schedule Apadaz as a C-II product and will provide an allocation of the Active Pharmaceutical Ingredient (API) consistent with those scheduling provisions,” said Travis Mickle, PhD, KemPharm President and Chief Executive Officer.
“This prompt decision by the DEA essentially completes the regulatory process with both Agencies and allows us to shift our focus towards the product launch.”
Apadaz will be supplied as a 6.12 mg/325 mg tablet.