MediQuest MQX-503 in position to be first Raynaud’s NDA filing
This article was originally published in Pharmaceutical Approvals Monthly
Executive Summary
MediQuest submits a 505(b)(2) NDA on April 25 for the topical nitroglycerin formulation MQX-503 for treatment and prevention of the chronic vasospasm episodes that occur in the extremities of patients with Raynaud's phenomenon. The company is seeking priority review. The locally-acting nitroglycerin gel, formerly called Vascana, restores blood flow rapidly, according to MediQuest. A Phase III "in-life" study was conducted under a special protocol assessment. "MQX-503 was a particularly good candidate for an SPA because there are no other drug therapies available for patients suffering from Raynaud's disease and, therefore, no generally accepted precedents for study design," MediQuest said