Tribute Pharmaceuticals, a wholly owned subsidiary of Stellar Pharmaceuticals, has received Health Canada approval for CAMBIA for the acute treatment of migraine attacks with or without aura in adults.
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The company plans to launch CAMBIA (diclofenac potassium for oral solution) in Canada in the second half of 2012.
The water-soluble, buffered diclofenac potassium powder was developed leveraging APR Applied Pharma Research’s absorption-enhancing technology, Dynamic Buffering Technology.
In the trials, CAMBIA was shown to be effective not only in treating migraine pain, but also photophobia, phonophobia, and nausea, symptoms commonly associated with migraine attacks.
CAMBIA has reached statistical significance in study patients treated with moderate-to severe migraine pain, the company said.
CAMBIA is marketed by Tribute under an exclusive Canadian license from Nautilus who obtained exclusive US and Canadian marketing rights for CAMBIA from APR in 2005.
Stellar president and CEO Rob Harris said with CAMBIA, Canadian physicians now have a new treatment option with comparable efficacy to the oral triptans but with a faster onset of action.
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