Pink Sheet is part of Informa PLC

This site is operated by a business or businesses owned by Informa PLC and all copyright resides with them. Informa PLC’s registered office is 5 Howick Place, London SW1P 1WG. Registered in England and Wales. Number 8860726.

This copy is for your personal, non-commercial use. For high-quality copies or electronic reprints for distribution to colleagues or customers, please call +44 (0) 20 3377 3183

Printed By

UsernamePublicRestriction
UsernamePublicRestriction

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

Topics

UsernamePublicRestriction

Register

PS003839

Ask The Analyst

Please Note: You can also Click below Link for Ask the Analyst
Ask The Analyst

Your question has been successfully sent to the email address below and we will get back as soon as possible. my@email.address.

All fields are required.

Please make sure all fields are completed.

Please make sure you have filled out all fields

Please make sure you have filled out all fields

Please enter a valid e-mail address

Please enter a valid Phone Number

Ask your question to our analysts

Cancel