Omeprazole/Antacid-Powder Suspension – Santarus: Omeprazole/Sodium Bicarbonate Powder – Santarus, SAN 05
Author: Adis International Limited
Source: Drugs in R&D, Volume 5, Number 6, 2004 , pp. 349-350(2)
Publisher: Adis International
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Abstract:
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. This omeprazole powder suspension will be used to treat gastrointestinal haemorrhage, gastro-oesophageal reflux disease, heartburn and peptic ulcers.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 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 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) 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 40mg powder suspension for an 8-week period.In connection with the NDA for omeprazole powder suspension 40mg, Santarus provided notice to the NDA holder for Prilosec® delayed-release capsules and related patent owners that omeprazole powder suspension 40mg does not infringe currently listed patents for Prilosec® or that those patents are invalid.Document Type: Research article
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