Medication Monitor

Generic Name (Trade Name—Company)
March 1, 2018

Benzhydrocodone and acetaminophen

FDA approves benzhydrocodone/acetaminophen for short-term management of acute pain

KemPharm announced FDA approval of benzhydrocodone/acetaminophen for the 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. 

The drug is an immediate release (IR) combination of KemPharm’s prodrug, benzhydrocodone, and acetaminophen (APAP).

Benzhydrocodone is a Schedule II controlled substance that can be abused and is subject to misuse, addiction, and criminal diversion.

Approval was based in part on pharmacokinetic studies with Vicoprofen, Ultracet, and Norco, in which benzhydrocodone/acetaminophen demonstrated exposure to hydrocodone and acetaminophen (APAP) that is expected to result in therapeutic effects equivalent to currently approved immediate-release hydrocodone/APAP combination products when administered orally as intended.

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

The drug is contraindicated in patients with significant respiratory depression; acute or severe bronchial asthma in an unmonitored setting or in absence of resuscitative equipment; known or suspected gastrointestinal obstruction, including paralytic ileus; and hypersensitivity to hydrocodone or acetaminophen.