oxycodone + acetaminophen (Forte Bio-Pharma)

Prolate OS is an FDA-approved oral solution formulation of oxycodone hydrochloride and acetaminophen, developed by Forte BioPharma. It is indicated for the management of pain severe enough to require an opioid analgesic and for which alternative treatments are inadequate. Oxycodone acts as a mu-opioid receptor agonist, providing potent analgesia through the central nervous system, while acetaminophen provides non-opioid analgesia and antipyretic effects, likely through the inhibition of cyclooxygenase enzymes. As an opioid-containing product, Prolate OS is subject to the FDA's Opioid Analgesic Risk Evaluation and Mitigation Strategy (REMS) program due to the significant risks of addiction, abuse, misuse, and potentially fatal respiratory depression.

Brand names

Prolate OSProlate

Other names

oxycodone hydrochloride and acetaminophen oral solution