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PA32540
PA32540 is a fixed-dose combination of acetaminophen and a nonsteroidal anti-inflammatory drug (NSAID) designed to provide enhanced pain relief with potentially improved gastrointestinal safety.
PA32540 is a fixed-dose combination of acetaminophen and a nonsteroidal anti-inflammatory drug (NSAID) designed to provide enhanced pain relief with potentially improved gastrointestinal safety. Used for Acute pain management (Phase 3 development).
At a glance
| Generic name | PA32540 |
|---|---|
| Also known as | YOSPRALA |
| Sponsor | POZEN |
| Drug class | Fixed-dose combination analgesic (acetaminophen + NSAID) |
| Target | COX-1 and COX-2 (NSAID component); central pain pathways (acetaminophen component) |
| Modality | Small molecule |
| Therapeutic area | Pain Management |
| Phase | Phase 3 |
Mechanism of action
PA32540 combines acetaminophen with an NSAID in a single formulation to leverage synergistic analgesic effects while potentially reducing NSAID-related gastrointestinal toxicity through optimized dosing. The combination targets multiple pain pathways—acetaminophen via central COX inhibition and the NSAID via peripheral COX inhibition—to achieve greater efficacy at lower individual doses.
Approved indications
- Acute pain management (Phase 3 development)
Common side effects
- Gastrointestinal upset
- Nausea
- Dyspepsia
- Headache
Key clinical trials
- A Study to Evaluate the Incidence of Gastric Ulcers Following Administration of Either PA32540 or Enteric Coated Aspirin 325 mg in Subjects Who Are at Risk for Developing Aspirin-Associated Ulcers (PHASE3)
- Study to Evaluate the Incidence of Gastric Ulcers Following Administration of Either PA32540 or Enteric Coated Aspirin 325 mg in Subjects Who Are at Risk for Developing Aspirin-Associated Ulcers (PHASE3)
- Study to Evaluate the Long-Term Safety of PA32540 in Subjects Who Are at Risk for Developing Aspirin-Associated Gastric Ulcers (PHASE3)
- A Study to Evaluate Platlet Aggregation of Clopidogrel, EC Aspirin 81 mg, EC Omeprazole 40 mg Compare to PA32540 (PHASE1)
- Study Evaluating the Effect on Gastroduodenal Mucosa of PA32540, PA32540 and Celecoxib, and Aspirin With Celecoxib (PHASE1)
- Evaluate Relative Bioavailability of PA32540 (Asa/Omeprazole), Its Aspirin Component, and Ecotrin® in Healthy Volunteers (PHASE1)
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 |