Budesonide MMX®

Budesonide MMX^® is a corticosteroid inserted in a MMX^® technology formulation that acts as an anti-inflammatory pharmaceutical product. It is the active ingredient in a number of treatments for asthma, non-infectious rhinitis (including hay fever and other allergies), nasal polyposis and Crohn's Disease. Budesonide MMX^® is currently being clinically developed by Cosmo and Phase III clinical trials have been completed.

Budesonide MMX® is an oral tablet formulation which delivers Budesonide directly to the lumen of the colon. The specific pharmaceutical product dissolution profile increases the colonic specific bio-availability of Budesonide and reduces the pre-colonic systemic absorption. The intended reduction of systemic absorption reduces side effects associated with pharmaceutical product treatment while the intended delivery to the colon enables the product to be especially effective in the treatment of proximal and distal Ulcerative Colitis. Phase III clinical trials have been completed in the USA and EU and the filing of the MAA in the Netherlands for 15 EU countries was made in May 2011 and the filing of the NDA is expected in H2 2011.

Cosmo's patent expires in the year 2020.