Pain-Free Response at 2 Hours1-3

Diener study design: A randomized, double-blind, double-dummy, multicenter, cross-over trial comparing the safety and efficacy of 50 mg diclofenac potassium sachets (n=291), 50 mg diclofenac potassium tablets (n=298), and placebo (n=299) in patients with migraine pain.
Lipton study design: Phase III, prospective, randomized, double-blind, parallel-group, single-dose, placebo-controlled, multicenter, safety and efficacy study assessing the efficacy of diclofenac potassium 50 mg (n=343) for oral solution vs placebo (n=347) for the treatment of migraine pain.
  • Primary End Point: Pain-Free Response at 2 Hours2

    Diener Study2

    24.7%

    versus 11.7% for placebo (P<.0001)

    Assessing the efficacy of diclofenac potassium 50 mg (n=291) for oral solution vs placebo (n=299) for the treatment of migraine pain.

  • Co-Primary End Point: Pain-Free Response at 2 Hours3

    Lipton Study3

    25.1%

    versus 10.1% for placebo (P<.001)

    Assessing the efficacy of diclofenac potassium 50 mg (n=343) for oral solution vs placebo (n=347) for the treatment of migraine pain.

IMPORTANT SAFETY INFORMATION

WARNINGS AND PRECAUTIONS
Cardiovascular Thrombotic Events
Clinical trials of several COX-2 selective and nonselective NSAIDs of up to three years duration have shown an increased risk of serious cardiovascular (CV) thrombotic events, including myocardial infarction (MI) and stroke, which can be fatal.

To minimize the potential risk for an adverse CV event in NSAID-treated patients, use the lowest effective dose for the shortest duration possible. Physicians and patients should remain alert for the development of such events, throughout the entire treatment course, even in the absence of previous CV symptoms. Patients should be informed about the symptoms of serious CV events and the steps to take if they occur.

Post-MI Patients
Avoid the use of CAMBIA in patients with a recent MI unless the benefits are expected to outweigh the risk of recurrent CV thrombotic events. If CAMBIA is used in patients with a recent MI, monitor patients for signs of cardiac ischemia.

Treat Multiple Symptoms of Migraine3

Lipton study design: Phase III, prospective, randomized, double-blind, parallel-group, single-dose, placebo-controlled, multicenter, safety and efficacy study assessing the efficacy of diclofenac potassium 50 mg (n=343) for oral solution vs placebo (n=347) for the treatment of migraine pain.

Co-Primary End Points: Lipton Study3

  • Nausea-free response at 2 hours3

    64.7%

    versus 52.7% for placebo (P<.002)

  • Photophobia-free response at 2 hours3

    40.5%

    versus 27.4% for placebo (P<.001)

  • Phonophobia-free response at 2 hours3

    44.3%

    versus 27.4% for placebo (P<.001)

The International Headache Society states in the diagnostic criteria for migraine that in addition to pain, a person must also experience at least 1 of the following during the headache4:

  1. Nausea and/or vomiting
  2. Photophobia
  3. Phonophobia

Watch Video About Acute Treatment of Migraine

New evidence from the American Headache Society (AHS) presented by Dr. Alan M. Rapoport, Clinical Professor of Neurology, The David Geffen School of Medicine, UCLA.

*AHS 2015 Assessment stated that the use of diclofenac for the acute treatment of migraine was supported by Level A evidence based on the review of 4 Class 1 studies.

IMPORTANT SAFETY INFORMATION

WARNINGS AND PRECAUTIONS (CONTINUED)
Gastrointestinal Bleeding, Ulceration, and Perforation
NSAIDs, including diclofenac, cause serious gastrointestinal (GI) adverse events including inflammation, bleeding, ulceration, and perforation of the esophagus, stomach, small intestine, or large intestine, which can be fatal. These serious adverse events can occur at any time, with or without warning symptoms, in patients treated with NSAIDs. Only one in five patients who develop a serious upper GI adverse event on NSAID therapy is symptomatic.

See full Prescribing Information for more information.

References

1. CAMBIA [package insert]. Newark, CA: Depomed, Inc; 2016. 2. Diener HC, Montagna P, Gács G, et al. Efficacy and tolerability of diclofenac potassium sachets in migraine: a randomized, double-blind, cross-over study in comparison with diclofenac potassium tablets and placebo. Cephalalgia. 2006;26(5):537-547. 3. Lipton RB, Grosberg B, Singer RP, et al. Efficacy and tolerability of a new powdered formulation of diclofenac potassium for oral solution for the acute treatment of migraine: results from the International Migraine Pain Assessment Clinical Trial (IMPACT). Cephalalgia. 2010;30(11):1336-1345. 4. Headache Classification Committee of the International Headache Society (IHS). The International Classification of Headache Disorders, 3rd edition (beta version). Cephalalgia. 2013;33(9):629-808. 5. Marmura MJ, Silberstein SD, Schwedt TJ. The acute treatment of migraine in adults: the American Headache Society evidence assessment of migraine pharmacotherapies. Headache. 2015;55(1):3-20.