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FDA approves Apadaz™ - new short-acting opioid analgesic for acute pain

Optum Workers' Comp
| Mar 01, 2018

KemPharm, Inc. announced that the U.S. Food and Drug Administration (FDA) approved its New Drug Application (NDA) for Apadaz (benzhydrocodone and acetaminophen), an immediate-release (short-acting) opioid analgesic combination product. Apadaz is intended for the short-term (no more than 14 days) management of acute pain that is severe enough to require an opioid analgesic and for which alternative treatments are inadequate. 

Benzhydrocodone is a prodrug to hydrocodone, meaning it is chemically inactive on its own. When the medication is ingested (swallowed), digestive enzymes in the gastrointestinal tract convert benzhydrocodone to hydrocodone, the active ingredient that exerts its therapeutic effect. The FDA’s approval was based in part by studies with various short-acting opioid combination products, including Vicoprofen®, Ultracet® and Norco®. As a result, when taken as directed, Apadaz is expected to exert therapeutic effects similar to other currently available, short-acting hydrocodone and acetaminophen products, such as Vicodin®, Lortab® and Norco®. However, Apadaz did not demonstrate abuse-deterrence by current measurement standards and is therefore not labeled as an abuse-deterrent formulation or ADF.

The U.S. Drug Enforcement Agency (DEA) intends to designate Apadaz as a schedule II controlled substance, similar to hydrocodone and acetaminophen products. A schedule II controlled substance means these medications have a high potential for abuse, which may lead to severe psychological and physical dependence. Product launch plans are unknown at this time. We will continue to follow the development and market launch of this medication as it becomes available.  

The pharmaceutical company’s strategy is to employ its platform technology, known as Ligand Activated Therapy (LAT™), to “discover and develop prodrugs that are new molecules that can improve one or more of the attributes of approved drugs, such as susceptibility to abuse, bioavailability and safety.”  For more information on KemPharm and its pipeline of prodrug product candidates, visit


  1. FDA Approves Apadaz (benzhydrocodone and acetaminophen) for the Short-Term Management of Acute Pain. February 23, 2018. Available at
  2. KemPharm, Inc. News Release. KemPharm Announces FDA Approval of Apadaz™ (benzhydrocodone and acetaminophen) for the Short-Term Management of Acute Pain. February 23, 2018. Available at


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