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.

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

The Cambia drug label comes with the following Black Box Warning: Non-steroidal anti-inflammatory drugs (NSAIDs) cause an increased risk of serious cardiovascular thrombotic events, including myocardial infarction and stroke, which can be fatal. This risk may occur early in treatment and may increase with duration of use. Cambia is contraindicated in the setting of coronary artery bypass graft (CABG) surgery. NSAIDs cause an increased risk of serious gastrointestinal (GI) adverse events including bleeding, ulceration, and perforation of the stomach or intestines, which can be fatal. These events can occur at any time during use and without warning symptoms. Elderly patients and patients with a prior history of peptic ulcer disease and/or GI bleeding are at greater risk for serious GI event.

Clinical Trial Results

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%