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hydrocodone/APAP w placebo PRN
Hydrocodone is an opioid agonist that binds to mu opioid receptors in the central nervous system to reduce pain perception, while acetaminophen (APAP) inhibits prostaglandin synthesis to provide additional analgesic and antipyretic effects.
Hydrocodone is an opioid agonist that binds to mu opioid receptors in the central nervous system to reduce pain perception, while acetaminophen (APAP) inhibits prostaglandin synthesis to provide additional analgesic and antipyretic effects. Used for Moderate pain (marketed combination indication).
At a glance
| Generic name | hydrocodone/APAP w placebo PRN |
|---|---|
| Also known as | Lortab |
| Sponsor | VA Office of Research and Development |
| Drug class | Opioid analgesic combination |
| Target | Mu opioid receptor (hydrocodone); cyclooxygenase enzymes (acetaminophen) |
| Modality | Small molecule |
| Therapeutic area | Pain Management |
| Phase | FDA-approved |
Mechanism of action
Hydrocodone acts as a mu opioid receptor agonist, modulating pain signals in the brain and spinal cord. Acetaminophen works through a separate mechanism involving inhibition of cyclooxygenase enzymes and prostaglandin production. The combination provides synergistic pain relief. The 'w placebo PRN' notation indicates this is a formulation used in a clinical trial or research setting with placebo control and as-needed dosing.
Approved indications
- Moderate pain (marketed combination indication)
Common side effects
- Constipation
- Nausea
- Dizziness
- Drowsiness
- Respiratory depression
- Hepatotoxicity (acetaminophen)
Key clinical trials
Primary sources
Every claim on this page is sourced from regulatory or scientific primary sources. See our editorial policy for full methodology.
| Source | Used for |
|---|---|
| ClinicalTrials.gov | Trial enrolment, design, endpoints, results |
Competitive intelligence
For the full competitive landscape — auto-detected comparators, recent regulatory actions across the set, upcoming PDUFA, patent timeline, sponsor landscape:
- hydrocodone/APAP w placebo PRN CI brief — competitive landscape report
- hydrocodone/APAP w placebo PRN updates RSS · CI watch RSS
- VA Office of Research and Development portfolio CI