Apadaz™ Approved for Short-term Management of Acute Pain

Kathy Tiemeier
RPh, DAIPM, Sr. Clinical Account Executive

Recently, the U.S. Food and Drug Administration (FDA) approved KemPharm’s Apadaz™ (benzhydrocodone and acetaminophen) for the short-term management (no more than 14 days) of acute pain severe enough to require an opioid analgesic and for which alternative treatments are inadequate.

Apadaz is the first prodrug of hydrocodone/acetaminophen to receive FDA approval. What makes Apadaz unique is that the prodrug (benzhydrocodone) is chemically inactive by itself. The benzhydrocodone becomes active when it is acted upon by enzymes in the gastrointestinal tract, releasing the hydrocodone (parent drug) which can then exert its therapeutic effect.

While the product has differentiation because of its Ligand Activated Therapy (LAT™) pro-drug platform, KemPharm was not successful in obtaining FDA’s approval for abuse-deterrent labeling because it did not meet the requirements by today’s standards of measurement.

Apadaz will be available as a C-II controlled substance and in 6.12 mg benzhydrocodone/325 mg acetaminophen immediate-release tablets. Treatment with Apadaz should be initiated at 1 or 2 tablets every 4-6 hours as needed for pain. Dosage should not exceed 12 tablets in a 24 hour period. 6.12 mg of benzhydrocodone is equivalent to 4.54 mg hydrocodone or 7.5mg hydrocodone bitartrate.

Because of the risks of addiction, abuse, and misuse with opioids, even at recommended doses, Apadaz should be reserved for use in patients for whom alternative treatment options [e.g., non-opioid analgesics] have not been or are not expected to be tolerated, or have not provided adequate analgesia, or are not expected to provide adequate analgesia

Complete prescribing information for Apadaz is available at:
http://kempharm.com/apadaz/apadaz-materials-and-resources/#