Posted from: Thursday, February 07, 2019 - 05:21 PM - Present

New Apadaz Dosage Strengths Approved

January 7, 2019 – The U.S. FDA has approved two new dosage strengths for Apadaz® (benzhydrocodone/ acetaminophen) tablets, manufactured by KemPharm. Apadaz is indicated to provide short-term (no more than 14 days) management of acute pain severe enough to require an opioid analgesic and for which alternative treatments are inadequate.

Apadaz received FDA approval for a benzhydrocodone 6.12mg/acetaminophen 325mg dosage strength in February 2018. The new FDA approval is for a benzhydrocodone 4.08mg/acetaminophen 325mg dosage strength and a benzhydrocodone 8.16mg/acetaminophen 325mg dosage strength.

Recommended dosing for initial treatment is one or two tablets taken every four hours as needed for pain. Patients should not exceed 12 tablets in a 24-hour period, and dosing should be adjusted as needed based on individual patient factors. Due to the risks associated with Apadaz, patients should receive the lowest possible dose for the shortest duration of time consistent with treatment goals.

Apadaz carries several black box warnings detailing the risks of addiction, abuse, and misuse; respiratory depression; accidental ingestion; neonatal opioid withdrawal syndrome; hepatotoxicity; and risks associated with concomitant use of central nervous system depressants or CYP3A4 inhibitors. Apadaz will be dispensed under a Risk Evaluation and Mitigation Strategy (REMS) program.

KemPharm has not yet launched any of the three dosage strengths or announced pricing plans.


Last Updated Friday, October 18, 2019 - 12:55 AM.