Diclofenac potassium for oral solution (CAMBIA^®) in the acute management of a migraine attack: clinical evidence and practical experience

Abstract

Abstract:Migraine headache affects about 12% of Western populations and is the third most common disease worldwide (sixth in terms of disability). In 1993, triptans were introduced in the United States as a new treatment for managing migraine attacks, but their use is limited by lack of response and safety concerns in some patients. Treatment options for patients with migraine who fail or cannot tolerate triptans include switching to another medication or adding an adjunctive medication. Desirable characteristics reported by patients for acute treatment of migraine attacks include complete pain relief, fast onset of action, and no pain recurrence. Diclofenac is a nonsteroidal anti-inflammatory medication that has been established as effective for acute treatment of migraine by the American Headache Society based on available evidence. Diclofenac potassium for oral solution is rapidly absorbed, achieving maximal plasma concentrations in 15 min, which coincides with a rapid onset of effect. In a comparison of diclofenac potassium for oral solution with diclofenac potassium tablets, the solution achieved a significant reduction in headache intensity beginning at 15 min compared with 60 min for the tablet. Across randomized clinical trials, approximately 25% of patients were pain free 2 h after administration of diclofenac oral solution and the effects were maintained over a 24-h period. Diclofenac potassium for oral solution is well tolerated; the most common adverse events are dizziness and gastrointestinal complaints, with incidences similar to placebo. No serious adverse events have been reported in clinical trials of diclofenac potassium for oral solution in the acute treatment of migraine. Diclofenac oral solution may offer rapid and sustained pain relief for patients who do not achieve pain resolution with other medications. In addition, patients who experience central sensitization with allodynia may benefit from the cyclooxygenase-blocking activity of diclofenac, which is needed in this advanced phase of migraine.

Self-administered subcutaneous diclofenac sodium in acute migraine attack: A randomized, double-blind, placebo-controlled dose-finding pilot study

“…Diclofenac is one of the most prescribed NSAIDs worldwide for the treatment of inflammatory disease and pain (33,34) and has an established role in the treatment of acute migraine. Oral diclofenac potassium in tablet, sachet or solution formulations has previously been shown to be effective, fast-acting, and welltolerated in the treatment of acute migraine attacks as an alternative to sumatriptan or other oral migraine therapies (35)(36)(37)(38)(39). Similarly, oral diclofenac epolamine is more effective than placebo in mild-to-moderate acute migraine, reducing time to attack resolution, impact on ability to work, and sensitivity to light and noise, compared with placebo (40).…”

A Review of Chronic Musculoskeletal Pain: Central and Peripheral Effects of Diclofenac

“…Diclofenac can also be suggested because of its effects on substance P, β-endorphin, and NMDA receptors, and the fact that many clinical studies have demonstrated that it relieves pain. It has been shown that patients suffering from migraine who experience central sensitization with allodynia and do not achieve pain relief with other medications may benefit from the cyclooxygenase-blocking activity of diclofenac [ 86 ]. Finally, diclofenac is available for treating pain in different formulations (oral, intramuscular, topical, etc.).…”

Diclofenac in the treatment of pain in patients with rheumatic diseases

“…Diclofenac in the chemical forms of acid, potassium salt or sodium salt is available on the pharmaceutical market in a large number of medicinal products in various dosage forms and with different routes of administration [ 35 , 36 ]. They include oral dosage forms (tablets, capsules), usually with modified release, rectal dosage forms, injections, products applied or sprayed on the skin, mucoadhesive dosage forms and eye drops [ 37 ].…”