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Cambia® (Diclofenac Potassium for Oral Solution) in the Management of Acute Migraine


patients with fewer than 10 migraines per month, use of NSAIDs has been shown to prevent progression from episodic migraine to chronic migraine.30


Figure 1: Efficacy of Cambia® Sachets in Acute Migraine— Data from the European Trial Two-hour Timepoint


Data from available placebo-controlled clinical trials indicate that diclofenac potassium is as effective as triptans and ergot-based medication, has a faster onset, and is better tolerated.31


Cambia® in the Treatment of Acute Migraine Cambia is a novel, patented formulation of diclofenac potassium that is the only prescription strength NSAID approved and indicated by the FDA for the acute treatment of migraine. It offers several advantages over conventional diclofenac tablets in that it is a 50 mg packet of powder that is buffered and used in solution to improve peak absorption of the medication.32


EU study: two-hour efficacy result p<0.0001‡ p=0.0035 p<0.0001


Consequently, when compared with oral diclofenac pills, peak absorption for Cambia occurs within 15 minutes in contrast to pills or other forms of non-buffered diclofenac for which peak absorption occurs around 60 minutes.33


Only injectable pharmacotherapies


are faster. This feature of rapid peak absorption is critical in the treatment of migraine because it has been shown that early intervention may reduce central sensitization in rat models,16


leading to supportive early treatment


research paradigms in humans, aimed at improving the acute treatment of migraine.34,35


Furthermore, Cambia’s buffered oral solution provides efficacy in such cases when the possibility of gastroparesis is of concern.


There have been two large pivotal multicenter trials of Cambia in the acute treatment of migraine—one in Europe27 and one in the US36


(International migraine pain assessment clinical trial


[IMPACT] study) (see Figures 3 and 4). The European trial was performed as a randomized, double-blind, double-dummy, cross-over study in 328 patients with migraine pain, treating 888 attacks. All patients in the trial reported pre-treatment headache intensity as moderate (approximately 50 %) and severe (approximately 40 %). The primary endpoint of being pain-free two hours post dose was achieved in 24.7 % of patients compared with diclofenac 50 mg pills (18.5 %) and placebo (11.7 %) (p<0.0001). Patients treated with Cambia had 46 % pain relief within two hours compared with diclofenac 50 mg pills (41 % p<0.0035) and placebo (24 % p<0.0001). Benefit began within 15 minutes of use compared with 60 minutes for diclofenac tablets. It was notable that 22.1 % of patients who were pain-free after using Cambia remained pain-free at 24 hours as opposed to 15.3 % with diclofenac and 9.4 % with placebo. Cambia and diclofenac tablets were both superior to placebo for two hour reduction of nausea, photophobia, and phonophobia.27


The US IMPACT trial was a randomized, double-blind, parallel-group, placebo-controlled study conducted in 23 US centers, involving 690 participants. Adult sufferers treated a moderate to severe attack with 50 mg Cambia (n=343) or placebo (n=347), similar to the European trial. Cambia resulted in a two-hour pain-free response (25 versus 10 % for placebo, p<0.001). The differences between Cambia and placebo were apparent at 30 minutes post dose with continued significant difference throughout all measured time points. Interestingly, 19 % of those receiving Cambia versus 7.2 % from the placebo group remained pain-free at 24 hours (p<0.001), and Cambia was again superior to placebo with patients being free from nausea, photophobia, and phonophobia.36


Side effects of Cambia in both studies were similar to placebo with overall incidence of all adverse events of about 6–7 %27


with the greatest US NEUROLOGY


10 20 30 40


5


Sustained headache response at 24 hours† 0


Cambia


15 25 35


(see Figures 1 and 2 and Table 2),


36.8 % n=107


10 20 30 40 50


15 25 35 45


5 0


p<0.0001‡ p=0.0035 p=0.0040


24.7 % n=72


18.5 % n=55


24.1 % n=72


11.7 % n=35


Pain-free at two hours* Cambia


Headache response at two hours† Diclofenac potassium tablet Placebo


*Primary efficacy result; †Secondary efficacy result; ‡Treatment comparison p values indicate only patients who received both treatments. Source: Diener et al., 2006.27


Figure 2: Efficacy of Cambia® Sachets in Acute Migraine— Data from the European Trial 24-Hour Timepoint


p<0.0001‡ p=0.0227 p<0.0001


30.9 % n=92


18.4 % n=55


p<0.0001‡ p=0.0005


22.3 % n=65


p=0.0077


15.1 % n=45


EU study: 24-hour efficacy result


46.0 % n=134


41.6 % n=124


9.4 % n=28


Diclofenac potassium tablet Pain-free at 24 hours†


Placebo


†Secondary efficacy result; ‡Treatment comparison p values indicate only patients who received both treatments. Source: Diener et al., 2006.27


side-effect reported for Cambia being nausea of 4.6 % compared with placebo of 3.5 %.36


Typically, long-term treatments involve medications used for acute attacks combined with preventative medications. Successful long-term treatment requires knowledge of potential interactions and contraindications. Concerns of serious adverse events have frequently resulted in insufficient treatment of the disorder.


Current long-term preventative treatments in migraine include cardiovascular drugs (propranolol and verapamil), beta blockers, calcium channel blockers, antidepressants (amitriptyline and protriptyline), anti-seizure drugs (topiramate, gabapentin, and valproate), selective serotonin re-uptake inhibitors, serotonin antagonists, and recently, botulinum toxin type A.37–39


141


Patients (%)


Patients (%)


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