IM Ketorolac vs Cambia for the Acute Treatment of Severe Migraine

The treatment of severe migraine often requires a patient office visit or treatment in the
ER or urgent care setting. This is due to the minimal efficacy of PO treatments once
migraine is severe, and therefore the need for parenteral treatments. IM Ketorolac is one
mainstay of parenteral treatment. There is an unmet need for effective at-home treatment
regimens for severe migraine. Despite FDA approval of Cambia for acute migraine treatment,
insurance is reticent to cover the treatment due to higher cost in comparison to generic
diclofenac tablets, despite superior efficacy of Cambia in comparison to generic diclofenac
tablets (Diener, Cephalalgia 2006). One objective of this study would be to provide
rationale to justify the insurance coverage of this treatment in comparison to generic
tablets, because at home treatment is less costly than office visit or emergency department
visit to receive IM ketorolac.

A previous study of Cambia demonstrated that this formulation of diclofenac potassium for
oral solution is effective in reducing pain intensity within 30 minutes, which may be
related to the 15-minute Tmax associated with this formulation. The rapid-onset benefits
were sustained through 24 hours post-treatment (Lipton, Cephalalgia 2010)

Inclusion Criteria:

- Patients who meet IHS criteria for migraine

- Age 18 to 65

- At least 2 migraine attacks per month

- Able to give written consent

- Willing to complete the entire course of the study

- Current headache duration greater than or equal to 36 hours

Exclusion Criteria:

- Pregnant or nursing

- Significant medical or psychiatric disease

- History of gastritis, gastric ulcer, GI bleed

- Renal insufficiency

- Hepatic insufficiency

- History of opioid dependence within the last 10 years or currently

- Any current or prior use of DICLOFENAC POTASSIUM POWDER FOR ORAL SOLUTION (CAMBIA)

- Past allergic reaction to DICLOFENAC or other NSAIDs