Santarus Inc. is developing an immediate-release formulation of
omeprazole in combination with an
antacid (
sodium bicarbonate) as a
powder for
suspension, known as Acitreltrade mark [
SAN 05] and also as
Rapinex powder for oral
suspension. This
omeprazole powder suspension will be used to treat gastrointestinal haemorrhage,
gastro-oesophageal reflux disease,
heartburn and
peptic ulcers. Acitreltrade mark 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 gastrointestinal (GI) diseases. Santarus has licensed exclusive, worldwide rights to patent applications covering specific combination formulations of
proton pump inhibitors (PPIs) and
antacids for treating various upper GI diseases and disorders. Santarus plans to license the development, distribution and marketing rights of
omeprazole powder for oral
suspension 20 mg 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 40 mg) with 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 this
omeprazole 40 mg
powder suspension for an 8-week period. In connection with the NDA for
omeprazole powder suspension 40 mg, Santarus provided notice to the NDA holder for
Prilosec delayed-release capsules and related patent owners that
omeprazole powder suspension 40 mg does not infringe currently listed patents for
Prilosec or that those patents are invalid.