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FDA Accepts for Filing New Drug Application for Rapinex
Pursuant to Prescription Drug User Fee Act (PDUFA) guidelines, Santarus expects the FDA will complete its review or otherwise respond to the Rapinex 40mg NDA by December 26, 2004. The company submitted the NDA for Rapinex 40mg in February 2004. In August 2003, Santarus submitted an NDA for Rapinex powder for oral suspension 20mg, seeking approval for treatment of heartburn and other symptoms related to gastroesophageal reflux disease (GERD), treatment and maintenance of healing of erosive esophagitis and treatment of duodenal ulcer, and expects FDA review or other response under PDUFA by June 15, 2004.
"The FDA's acceptance of this NDA marks an important milestone as we move to commercialize products for the prevention and treatment of GI diseases and disorders," said Gerald T. Proehl, president and chief executive officer. "This is the second NDA filing of a product based on our powder for oral suspension formulation, which may be desirable for hospitalized patients and the elderly, who may prefer or require a liquid formulation."
The NDA for Rapinex 40mg contained data from a pivotal Phase III clinical trial with 359 critically ill patients. Given the serious medical condition of the patient population, the blinded clinical trial compared Rapinex 40mg, administered through a nasogastric tube, with intravenous (IV) cimetidine, an H2-receptor antagonist, rather than with a placebo. IV cimetidine is the only drug currently approved by the FDA for the prevention of upper GI bleeding in critically ill patients. The primary endpoint of the Rapinex 40mg Phase III trial, the occurrence of clinically significant bleeding, was the same as that seen in the IV cimetidine trial that led to its approval. Santarus also conducted an open-label clinical trial treating 243 patients, including 97 patients with gastric ulcers, to collect safety data related to Rapinex 40mg over an 8-week treatment period, and has provided that data to the FDA as additional support for the product candidate's approval.
In connection with the filing of the Rapinex 40mg NDA, Santarus provided notice to the NDA holder for Prilosec(R) delayed-release capsules and related patent holders that Rapinex 40mg does not infringe the patents listed in the Orange Book for Prilosec or that those patents are invalid.
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.