April 19, 2010 - Migraine sufferers will soon have a new option for the acute treatment of migraines. Study results published in Cephalalgia, the international journal of headache, demonstrated that CAMBIATM (diclofenac potassium for oral solution made by Nautilus Neurosciences, Inc.) reduced migraine pain within 30 minutes thanks to the unique formulation which allows for high rates of absorption.
The results of the International Migraine Pain Assessment Clinical Trial (IMPACT) showed clinically significant improvement following treatment with CAMBIA in all four FDA-mandated co-primary endpoints for migraine pain, nausea, photophobia and phonophobia.
Secondary endpoints included reduction in pain-intensity difference (PID) at each evaluation time, sustained pain-free response, headache response, presence or absence of vomiting, frequency of headache recurrence and improvement in the ability to function. The study found that pain-intensity differences between treatments were significantly lower in patients treated with CAMBIA starting at 30 minutes post treatment, with significant differences at all time points thereafter, and sustained pain-free response over 24 hours.
A novel, water-soluble, buffered diclofenac potassium powder, CAMBIA is the only prescription non-steroidal anti-inflammatory drug (NSAID) indicated for the acute treatment of migraine with or without aura. Engineered using Dynamic Buffering Technology TM (DBT), a patented absorption-enhancing technology, CAMBIA enters a patient’s system quickly and readily achieves peak plasma concentrations, yet CAMBIA does not increase the patient’s total exposure to diclofenac. CAMBIA is not indicated for prophylactic therapy or cluster headache.
As with all NSAIDs, there is a risk of cardiovascular events such as myocardial infarction and stroke as well as an increased risk of gastrointestinal bleeding and ulceration. CAMBIA should not be taken concomitantly with acetaminophen due to risk of liver damage or with other NSAIDs due to bleeding risk. Caution is advised when using CAMBIA in patients with hypertension, ulcers, cardiovascular conditions, liver damage, renal impairment or who are pregnant or nursing.
Nautilus Neurosciences is expected to launch CAMBIA in the first half of 2010.
For more information, please go to http://www.nautilusneurosciences.com/Cambia_PI.pdf
