Santarus Inc., is developing an immediate-release formulation of
omeprazole in combination with an
antacid (
sodium bicarbonate) as a
powder for
suspension, known as
Acitrel [
SAN 05], and also as
Rapinex powder for oral
suspension.
Acitrel is based on technology licensed from the University of Missouri. Santarus have also licensed technology from Tulane and North Carolina Universities relating to potential treatments for GI diseases. Santarus have licensed exclusive, worldwide rights to patent applications covering specific combination-formulations of
proton pump inhibitors and
antacids for treating various upper GI diseases and disorders. Santarus plans to license development, distribution and marketing rights of
Rapinex Powder for oral
suspension 20mg outside the US, to one or more well established
pharmaceutical companies. The US FDA has requested that Santarus pursue a name other than
Rapinex for the product. Santarus is currently discussing potential alternative names for the product with the FDA. Santarus announced positive results, in August 2003, from a phase III trial comparing oral
Acitrel (
Rapinex 40mg) to intravenous
cimetidine in preventing upper GI
bleeding in 359
critically ill adult patients. Santarus has also completed an open-label clinical trial in 243 patients, including 97 patients with
gastric ulcers, evaluating the safety of
Rapinex 40mg for an 8-week period. In connection with the NDA for
Rapinex 40mg, Santarus provided notice to the NDA holder for
Prilosec delayed-release capsules and related patent owners that
Rapinex 40mg does not infringe currently listed patents for
Prilosec or that those patents are invalid.