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FDA Approves Powder Version of Omeprazole
"Rapinex Powder for Oral Suspension 20mg is the first FDA approved immediate-release oral PPI product that combines potent acid suppression, demonstrated safety, once-a-day dosing and rapid reduction in gastric acidity," said Gerald T. Proehl, president and chief executive officer of Santarus. "We believe that Rapinex represents an important new treatment option for patients and physicians. To supplement our product's broad indications approved for adult use, we plan to initiate clinical trials in 2005 to evaluate the product in pediatric populations where a liquid, titratable dosage form may provide particular benefit.
"This is the first of our immediate-release PPI products to gain FDA approval in the $12.9 billion U.S. PPI market, which is dominated by five delayed-release brands," added Mr. Proehl. "Leading the marketing effort will be a senior management team with significant experience in commercializing GI products. Consequently we believe we are well positioned to successfully launch our first product later this year."
Santarus plans to begin selling Rapinex Powder for Oral Suspension 20mg during the fourth quarter of 2004 through a sales force of approximately 230 representatives, targeting high-prescribing physicians who treat GI diseases and disorders. Additionally, the company is evaluating pharmaceutical companies to assist in the commercialization of this product. Outside the U.S., Santarus intends to license development, distribution and marketing rights to one or more pharmaceutical companies with established commercialization capabilities.
About Rapinex (omeprazole)
Rapinex (omeprazole) Powder for Oral Suspension 20mg uses an antacid, instead of an enteric coating, to protect the omeprazole from acid degradation. When constituted with water to form a uniform suspension prior to administration, the formulation rapidly neutralizes acid in the stomach and allows rapid absorption of omeprazole into the bloodstream.
The company submitted NDAs for the 20mg and 40mg dose strengths of the powder for oral suspension products in August 2003 and February 2004, respectively. Santarus' NDA for the 40mg dose strength of the product seeks approval for the treatment of gastric ulcers and the prevention of upper GI bleeding in critically ill patients. No PPI is currently approved for the prevention of upper GI bleeding in this patient population. Pursuant to Prescription Drug User Fee Act (PDUFA) guidelines, Santarus expects the FDA will complete its review or otherwise respond to the Rapinex Powder for Oral Suspension 40mg NDA by December 26, 2004. Santarus' two other immediate-release omeprazole product candidates, the capsule and chewable tablet formulations in both 20mg and 40mg dose strengths, are expected to be evaluated in pivotal pharmacokinetic/pharmacodynamic (PK/PD) clinical trials later this year.
"The approval of Rapinex Powder for Oral Suspension 20mg validates our regulatory strategy," said Bonnie Hepburn, M.D., senior vice president, drug development and chief medical officer of Santarus. "We plan to follow the same regulatory pathway to approval with our 40mg dose of powder for oral suspension, and with our two solid dosage formulations of Rapinex."
In connection with the review of Santarus' NDA for Rapinex Powder for Oral Suspension 20mg product, the FDA has requested that the company pursue a name other than Rapinex for the product. Santarus is currently discussing potential alternative names for the product with the FDA.
Important Safety Information
Rapinex Powder for Oral Suspension is indicated first line for heartburn and other symptoms associated with GERD, erosive esophagitis, maintenance of healed erosive esophagitis, and active duodenal ulcer. The most frequently reported adverse events with Rapinex are headache, diarrhea, and abdominal pain. Symptomatic response to therapy does not preclude the presence of gastric malignancy. Atrophic gastritis has been noted occasionally in gastric corpus biopsies from patients treated long term with omeprazole.
PPIs are the most common prescription treatment option for upper GI diseases and disorders, including GERD, due to their potent acid suppression, demonstrated safety and once-daily dosing. However, all currently marketed PPIs are available for oral use only in delayed-release formulations. According to IMS Health, total U.S. market sales of PPI products were $12.9 billion in 2003, and prescriptions written in the U.S. for PPI products totaled 95.2 million in 2003, up 10% from 2002.
Source: Santarus, Inc.