Mitigate those Migraines

Diclofenac potassium has recently been established as an effective Level A treatment for acute migraine attacks.

Diclofenac potassium has recently been established as an effective Level A treatment for acute migraine attacks.

The first evidence-based assessment of acute migraine treatments in the last 14 years, published in the journal American Headache Society (AHS) hailed CAMBIA® (Diclofenac Potassium), first launched in 2010, as an independent option for adult migraine treatment, based on similar evidence for efficacy as seen with migraine-specific medicines.

The significance of diclofenac potassium use had vastly improved from its mediocre description of “probably effective,” in the American Academy of Neurology (AAN) 2000 Guidelines for acute treatment of migraine.

Millions of Americans were reported dissatisfied with current medications on the market. Stephen D. Silberstein, MD, FACP, leading headache specialist and co-author of the assessment commented, “Based on the data published in the last decade, our group now categorizes diclofenac potassium, including diclofenac potassium oral solution, as Level A. For clinicians, they can feel confident prescribing it as a first-line treatment option, based on the individual patient’s history and preferences.”

“Speed of action and efficacy,” said Silberstein, were the primary differences between CAMBIA and existing poplar migraine treatments.

The AHS Guidelines Committee included Silberstein, Michael J. Marmura, MD, and Todd J. Schwedt, MD, MSCI, who developed the AHS Assessment, which lends itself to a systematic review of clinical trials appraising the efficacy of acute migraine treatments versus placebo that were published in medical journals between 1998 and 2013.

Two Class studies referenced in the AHA Assessment showed patients taking CAMBIA 50 mg tablets were more likely to be headache-free at 2 hours than those on placebo and those prescribed diclofenac potassium 50 mg tablets. Also, the authors noted that CAMBIA oral solution was superior in improving key measures of migraine disease burden, including 2-hour headache freedom, freedom from nausea, and freedom from light and sound sensitivity compared with placebo.

The guidelines highlighted CAMBIA was not indicated for the “prophylactic therapy” of migraine. Safety and effectiveness of CAMBIA had not been established for cluster headache, which is present in an older, predominantly male population.

Contraindications include: known hypersensitivity to diclofenac or NSAIDs, pre-existing asthma, urticaria or allergic-type reactions after aspirin intake, and use during the peri-operative period of coronary artery bypass graft (CABG) surgery. However, the most common adverse reactions were reported as nausea and dizziness.

Regarding further research on CAMBIA’s potential effect on pediatric patients, Srinivas G. Rao, MD, PhD, Chief Medical Officer and Senior Vice President, Depomed, Inc, Newark, CA, stated in an email interview, “Yes, as part of our commitment to the FDA, we are currently studying the safety and tolerability of CAMBIA in pediatric patients in 2 studies, which are underway. The first study will evaluate CAMBIA for the acute treatment of migraine attacks with or without aura in patients aged 12-17 years and the second study will assess the treatment in patients aged 2-12 years with mild to moderate acute pain.”