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

Depomed submits Proquin XR

This article was originally published in Pharmaceutical Approvals Monthly

Executive Summary

Depomed files its once-daily, extended-release ciprofloxacin formulation Proquin XR for treatment of uncomplicated urinary tract infections, the firm announces July 20. The NDA is based on a single Phase III trial in 1,037 patients comparing a three-day course of Proquin XR to three days of twice-daily immediate release ciprofloxacin (Bayer's Cipro). The study showed an eradication rate of 93.4% for Proquin XR compared to 89.6% for Cipro. Depomed will highlight fewer gastrointestinal side effects; in the clinical trial Proquin patients had "five-fold fewer complaints of nausea and seven-fold fewer cases of diarrhea." Depomed's Gastric Retention technology provides for "preferential absorption in the upper intestine." The company is "in discussions with potential marketing partners" and "evaluating the opportunity to co-promote the product in certain markets"...
Advertisement

Topics

Advertisement
UsernamePublicRestriction

Register

PS002616

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