Nautilus claimed that, Cambia, a novel, water-soluble, buffered diclofenac potassium powder, is the only prescription non-steroidal anti-inflammatory drug (NSAID) available for the acute treatment of migraine.
Cambia is engineered using Dynamic Buffering Technology (DBT), a patented absorption-enhancing technology developed by APR Applied Pharma Research and is specifically designed for fast, effective relief from the symptoms of migraine.
Reportedly, the FDA approval of Cambia was based on two Phase 3 placebo-controlled trials showing that it was superior to placebo in all four FDA-mandated co-primary end points for migraine pain, nausea, photophobia and phonophobia.
Both studies also showed that reduction in pain intensity was significantly greater in the Cambia group than in the placebo group as early as 15 minutes following treatment, and headache response rates were superior to placebo for up to 24 hours.
James Fares, chairman and CEO, Nautilus, said: “The US availability of Cambia represents an important milestone for Nautilus and an important new product for the millions of Americans who suffer from migraines.
“The launch of Cambia further establishes our corporate commitment to bringing unique products to those in need and being a true partner with the migraine community. The unique formulation of Cambia provides a new treatment option that can reduce key migraine symptoms quickly, effectively and safely.”