Apadaz Approved for Short-Term Treatment of Acute Pain
February 23, 2018 – The U.S. FDA has approved Apadaz™ (benzhydrocodone/acetaminophen) tablets, manufactured by KemPharm. The drug is indicated to provide short-term management of acute pain requiring an opioid analgesic, and for which alternative treatments are inadequate.
A combination of acetaminophen and a prodrug form of hydrocodone (benzhydrocodone), Apadaz should be taken for no more than 14 days. Recommended dosing is one to two tablets every four to six hours, as needed. Patients should not take more than 12 tablets within a 24-hour period.
Prodrugs are designed to remain pharmacologically inactive until metabolized within the body. The hydrocodone component of Apadaz activates only when it comes into contact with enzymes inside of the gastrointestinal tract. The Drug Enforcement Administration (DEA) plans to classify Apadaz as a Schedule II controlled substance.
Apadaz carries a black box label that warns patients and prescribers of the risks of addiction, respiratory depression, liver damage, and overdose. The black box label also cautions that use of Apadaz during pregnancy can lead to neonatal opioid withdrawal syndrome. Due to these risks, the drug will be distributed under a Risk Evaluation and Mitigation Strategy (REMS), and be accompanied by a Medical Guide. Pricing and launch plans have not yet been announced.
Adverse reactions or quality problems experienced with the use of a recalled product may be reported to the FDA’s MedWatch Adverse Event Reporting Program either online, by U.S. mail or by fax.
- Complete and submit the report Online: www.fda.gov/medwatch/report.htm
- U.S. Mail or Fax: Download form www.fda.gov/MedWatch/getforms.htm or call 1-800-332-1088 to request a reporting form, then complete and return to the address on the pre-addressed form, or submit by fax to 1-800-FDA-0178
Actual drug patent expiration dates and availability of new medications are subject to change due to patent litigation, settlement agreements, additional patents, exclusivities, and final FDA approval. Distribution and availability of new medications at pharmacies may not occur immediately following FDA approval. Patients are advised to speak with their healthcare professional or pharmacist regarding appropriateness as well as actual availability.
*This is provided for information only. The reference to any medication above does not mean the medication is covered by your plan.