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Diclofenac Potassium for Oral Solution
Diclofenac potassium inhibits cyclooxygenase (COX) enzymes to reduce prostaglandin synthesis, thereby decreasing pain and inflammation.
Diclofenac Potassium for Oral Solution is a nonsteroidal anti-inflammatory drug (NSAID) developed by Depomed. It is used to treat pain and inflammation in various conditions. The drug works by inhibiting cyclooxygenase enzymes, reducing the production of prostaglandins that cause pain and inflammation. Despite its effectiveness, it carries risks such as gastrointestinal bleeding and cardiovascular events. The drug does not have an FDA label, which may affect its market presence and regulatory status.
At a glance
| Generic name | Diclofenac Potassium for Oral Solution |
|---|---|
| Also known as | Cambia |
| Sponsor | Depomed |
| Drug class | Nonsteroidal anti-inflammatory drug (NSAID) |
| Target | Cyclooxygenase-1 (COX-1) and Cyclooxygenase-2 (COX-2) |
| Modality | Small molecule |
| Therapeutic area | Pain Management / Rheumatology |
| Phase | FDA-approved |
Mechanism of action
Diclofenac is a nonselective NSAID that blocks both COX-1 and COX-2 enzymes, which are responsible for producing prostaglandins that mediate inflammation, pain, and fever. By reducing prostaglandin levels, the drug provides analgesic and anti-inflammatory effects. The potassium salt formulation allows for rapid oral absorption and faster onset of action compared to other diclofenac formulations.
Approved indications
- Acute pain management
- Mild to moderate pain with inflammation
Common side effects
- Gastrointestinal upset (dyspepsia, nausea)
- Abdominal pain
- Diarrhea
- Headache
- Dizziness
- Rash
- Increased liver enzymes
Key clinical trials
- KF2022#4-trial: Effects of a Beta Blocker and NSAID on CYP Mediated Drug Metabolism (NA)
- "Supracondylar Radial Nerve Block Guided by Ultrasound Versus Hematoma Block for Analgesic Management in Closed Reduction of Distal Radius Fractures" (NA)
- The Application of a Biphasic Calcium Sulfate Graft Material in Sinus Floor Elevation (NA)
- Outcomes of Enhanced Recovery After Cesarean (ERAC) Protocol (NA)
- Safety, Tolerability, Pharmacokinetics and Pharmacodynamics Evaluation of RPH-104 Administered at Different Doses to Patients With Acute Gout Attack (PHASE2)
- Evaluation of the Effects of Different Analgesics on Pericoronitis Pain and Quality of Life (PHASE4)
- Pharmacokinetics & Safety of Cambia® in Migraine With or Without Aura in 12-17 Year Olds (PHASE4)
- Pharmacokinetics & Safety of Diclofenac Potassium Oral Solution in Ped. Subjects (2-12 Yrs) With Mild-Mod. Acute Pain (PHASE4)
Patents
| Patent | Expiry | Type |
|---|---|---|
| US1234567 |
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 |
| FDA Orange Book | Patents + exclusivity |
Competitive intelligence
For the full competitive landscape — auto-detected comparators, recent regulatory actions across the set, upcoming PDUFA, patent timeline, sponsor landscape:
- Diclofenac Potassium for Oral Solution CI brief — competitive landscape report
- Diclofenac Potassium for Oral Solution updates RSS · CI watch RSS
- Depomed portfolio CI