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


PTI’s Oxytrex “Worth One More Shot” After Phase III Study Spoiled By Vioxx

This article was originally published in Pharmaceutical Approvals Monthly

Executive Summary

Inappropriate enrollment of former Vioxx patients in Pain Therapeutics’ Phase III trial of Oxytrex for severe osteoarthritic pain undermined the study’s statistical power and necessitates a new trial, according to PTI.

You may also be interested in...

Pain Therapeutics Revamps Oxytrex Program, Changes Phase III Protocol For Pain

Pain Therapeutics' new trial design for Oxytrex features ultra-low doses and a four-times-a-day dosing regimen, CEO Remi Barbier said May 4

Licensing In Brief

Merck drops Pargluva partnership: Additional trials needed to support approval of Bristol-Myers Squibb's Pargluva (muraglitazar) type 2 diabetes treatment prompt Merck to drop out of its co-development partnership with BMS. Bristol remains in discussions with FDA about what clinical studies would be required to settle questions about the cardiovascular safety of the dual peroxisome proliferator-activated receptor agonist. Merck and Bristol announced FDA's "approvable" action, based on cardiovascular safety concerns, on Oct. 18. The firms subsequently determined that approval and commercial success would require additional trials that could take up to five years. Pargluva is not the first PPAR agent to succumb to safety issues: Novo Nordisk/Dr. Reddy's ragaglitazar and Merck/Kyorin's MK-0767 were discontinued in 2003 in Phase III due to animal carcinogenicity findings, and AstraZeneca pushed back a planned Galida (tesaglitazar) NDA to 2007 to gather longer-term safety data (1Pharmaceutical Approvals Monthly July 2005, p. 24)…

FDA Priority Review Voucher Redemption Fee Set At $4.6 Million In FY 2011

Redeeming a priority review voucher obtained by developing a drug for a tropical disease will cost companies $6.1 million in fiscal 2011





Ask The Analyst

Ask the Analyst is free for subscribers.  Submit your question and one of our analysts will be in touch.

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