Clinical Edge

Summaries of Must-Read Clinical Literature, Guidelines, and FDA Actions

FDA Approves Apadaz for Acute Pain Relief

KemPharm, Inc. news release; 2018 Feb 23

KemPharm, Inc., has announced that the US Food and Drug Administration (FDA) approved its New Drug Application (NDA) for Apadaz for the short-term (no >14 days) management of acute pain severe enough to require an opioid analgesic and for which alternative treatments are inadequate. KemPharm, Inc.’s corporate headquarters is located in Coralville, IA.

Indications: Apadaz is an immediate release (IR) combination of KemPharm’s prodrug, benzhydrocodone, and acetaminophen (APAP).

Dosage strengths/administration: Immediate-release tablets: 6.12 mg benzhydrocodone (equivalent to 6.67 mg benzhydrocodone hydrochloride) and 325 mg acetaminophen. Patients should use the lowest effective dose for the shortest duration consistent with individual patient treatment goals. Individualized dosing is based on the severity of pain, patient response, prior analgesic experience, and risk factors for addiction, abuse, and misuse.

Adverse reactions: The most common adverse reactions (>5%) are nausea, somnolence, vomiting, constipation, pruritus, dizziness, and headache.


KemPharm announces FDA approval of Apadaz (benzhydrocodone and acetaminophen) for short-term management of acute pain. [news release]. Coralville, IA: KemPharm, Inc. February 23, 2018. Accessed March 15, 2018.