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Home | Clinical Trials

FDA Approved Drugs » 2009
Medical Areas: Neurology | Family Medicine

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Cambia (diclofenac potassium for oral solution)

The following drug information is obtained from various newswires, published medical journal articles, and medical conference presentations.

Company: Kowa Pharmaceuticals
Approval Status: Approved June of 2009
Treatment Area: migraine attacks

General Information

Cambia (diclofenac potassium) is a benzeneacetic acid derivative non-steroid anti-inflammatory drug (NSAID). The mechanism of action of Cambia, like that of other NSAIDs, is not completely understood but may be related to prostaglandin synthetase inhibition.

Cambia is specifically indicated for the acute treatment of migraine attacks with or without aura in adults (18 years of age or older).

Cambia is supplied as a powder designed to give 50mg of solution when mixed with water, for oral administration. The recommended initial dose is one packet (50mg) mixed with 1 to 2 ounces (30 to 60 mL) of water. Use the lowest effective dose for the shortest treatment duration.

Clinical Results

FDA Approval
The FDA approval of Cambia for migraines was based on the results of two randomized, double-blind, placebo-controlled trials. The subjects were instructed to treat a migraine of moderate to severe pain with 1 dose of study medication; they evaluated their headache pain 2 hours later. Associated symptoms of nausea, photophobia, and phonophobia were also evaluated. The proportion of subjects who were "sustained pain free", defined as a reduction in headache severity from moderate or severe pain to no pain at 2 hours post-dose without a return of mild, moderate, or severe pain and no use of rescue medication for 24 hours post-dose, was also evaluated. The percentage of subjects achieving pain freedom 2 hours after treatment and sustained pain freedom from 2 to 24 hours post-dose, as well as the percentage of subjects achieving pain relief 2 hours after treatment, was significantly greater in the Cambia arm compared with the placebo arm. The results are as follows:

Study One

  • 2-Hour Pain Free: Cambia-24% versus placebo- 13%
  • 2-24h Sustained Pain Free: 22% versus 10%
  • 2-Hour Pain Relief: 48% versus 13%
  • Study Two

  • 2-Hour Pain Free: Cambia- 25% versus placebo- 10%
  • 2-24h Sustained Pain Free:19% versus 7%
  • 2-Hour Pain Relief: 65% versus 41%
  • Side Effects

    Adverse events associated with the use of Cambia may include, but are not limited to, the following:

    • Nausea
    • Dizziness
    • Cardiovascular thrombotic events
    • Gastrointestinal effects
    • Hepatic effects
    • Hypertension
    • Congestive Heart Failure and Edema
    • Renal Effects
    • Anaphylactoid Reactions
    • Serious Skin Reactions

    Mechanism of Action

    Cambia (diclofenac potassium) is a benzeneacetic acid derivative non-steroid anti-inflammatory drug (NSAID). The mechanism of action of Cambia, like that of other NSAIDs, is not completely understood but may be related to prostaglandin synthetase inhibition.

    Literature References

    Rothrock JF PRO-513 for acute migraine treatment. Headache 2007 Nov-Dec;47(10):1459

    Messinger HB Trial of oral diclofenac for the acute treatment of common migraine attacks. Cephalalgia : an international journal of headache 1992 Apr;12(2):125

    Dahlöf C, Björkman R Diclofenac-K (50 and 100 mg) and placebo in the acute treatment of migraine. Cephalalgia : an international journal of headache 1993 Apr;13(2):117-23

    Massiou H, Serrurier D, Lasserre O, Bousser MG Effectiveness of oral diclofenac in the acute treatment of common migraine attacks: a double-blind study versus placebo. Cephalalgia : an international journal of headache 1991 May;11(2):59-63

    Additional Information

    For additional information regarding Cambia or migraine headaches, please visit the Cambia web page.


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