Apadaz (benzhydrocodone and acetaminophen immediate-release tablets; KVK-Tech) and its authorized generic AG-Apadaz will be available nationally beginning in November 2019 for the short-term (≤14 days) management of acute pain severe enough to require an opioid analgesic and for which alternative treatments are inadequate.
The product combines benzhydrocodone, an opioid agonist, and acetaminophen. 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. Approval was based on pharmacokinetic studies which showed that the therapeutic effects of Apadaz were expected to be similar to that of other immediate-release hydrocodone/acetaminophen combination products.
Apadaz, a Schedule II controlled substance, is expected to be available in 3 tablet strengths: 4.08mg benzhydrocodone (equivalent to 4.45mg benzhydrocodone hydrochloride) and 325mg acetaminophen; 6.12mg benzhydrocodone (equivalent to 6.67mg benzhydrocodone hydrochloride) and 325mg acetaminophen; 8.16mg benzhydrocodone (equivalent to 8.90mg benzhydrocodone hydrochloride) and 325mg acetaminophen. As with other opioid analgesics, healthcare professionals are encouraged to follow the Risk Evaluation and Mitigation Strategy (REMS) when prescribing Apadaz.
For more information visit apadaz.com.