Viagra For Pulmonary Arterial Hypertension Would Be Called Revatio
This article was originally published in The Pink Sheet Daily
Executive Summary
Pfizer's sildenafil NDA was submitted Dec. 2 and requests a priority review. Revatio would be marketed in a different color and shape than Viagra tablets to differentiate the product's indications for PAH and erectile dysfunction.
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Pfizer's NDA for use of sildenafil in pulmonary arterial hypertension is being submitted under the trade name Revatio instead of the established Viagra erectile dysfunction brand. The company is also making physical changes to differentiate the indications. "Revatio will be manufactured and marketed in a different dosage, color and shape than Viagra," Pfizer said Dec. 3. The company filed the NDA Dec. 2 and requested a priority review. Dosing in the 278-patient Phase III clinical study for PAH was 20 mg sildenafil taken three times daily. The primary efficacy endpoint was improved physical function, measured by a six-minute walk test. Pfizer has also initiated pediatric trials in primary pulmonary hypertension as part of its patent extension strategy for the PDE-5 inhibitor (1 (Also see "Viagra For Neonates? Pfizer To Study Pediatric Use In Pulmonary Hypertension" - Pink Sheet, 24 Jun, 2004.)). Revatio is one of two NDAs the company intends to file by year-end, Pfizer told investors Nov. 30 (2 (Also see "Exubera NDA Will Be Filed "Early" In 2005" - Pink Sheet, 30 Nov, 2004.)). The company also plans to re-submit its injectable COX-2 inhibitor parecoxib; the Bextra pro-drug was deemed "not approvable" in 2001. Pfizer recently revised Bextra labeling to add a "black box" warning on skin reactions and a contraindication following coronary artery bypass graft surgery (see 3 (Also see "Bextra Contraindicated In CABG Surgery Patients" - Pink Sheet, 3 Dec, 2004.)). - Mary Jo Laffler |