Pink Sheet is part of Pharma Intelligence UK Limited

This site is operated by Pharma Intelligence UK Limited, a company registered in England and Wales with company number 13787459 whose registered office is 5 Howick Place, London SW1P 1WG. The Pharma Intelligence group is owned by Caerus Topco S.à r.l. and all copyright resides with the group.

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


Statistics Bedeviled But Did Not Derail Cymbalta Fibromyalgia Approval

This article was originally published in Pharmaceutical Approvals Monthly

Executive Summary

Lilly ran into one review issue with its fibromyalgia NDA for Cymbalta (duloxetine) because it did not adhere to a "well established policy" of the FDA division responsible for analgesic drugs regarding imputation of missing data, a recurring statistical issue in pain drug reviews, review documents show

You may also be interested in...

FDA Advice On Missing Data May Be To Avoid Missing It In The First Place

FDA officials respond to the recommendations of a National Research Council Panel on handling missing data in clinical trials, giving early indications of how FDA could be viewing a forthcoming guidance on the issue.

InterMune Positive On Pirfenidone Despite Mixed Study Results

InterMune was left with a mixed bag when it released its major Phase III program of pirfenidone in idiopathic pulmonary fibrosis, which yielded conflicting primary endpoint results. But the company thinks there are enough tricks in that bag to win FDA approval

Lilly withdraws Cymbalta chronic pain sNDA

Lilly acknowledged the importance of using FDA's preferred statistical analysis methods when the firm withdrew its sNDA for Cymbalta (duloxetine) for chronic pain management. One of three new studies submitted did not meet its primary endpoint when analyzed by the FDA analgesic division's preferred statistical method for handling data for patients who don't complete the study: baseline observation carried forward. The study met its primary endpoint using an analytical method known as Mixed Model Repeated Measures; BOCF was a secondary endpoint. The sNDA withdrawal was prefigured by debate over the agency's preference for the more conservative imputation method during the review of Cymbalta's fibromyalgia indication (1Pharmaceutical Approvals Monthly November 2008, p. 42). Lilly expects to submit a revised application in the first half of 2009 that will include data from a recently completed study that the company said achieved statistical significance using both BOCF and MMRM

Related Content


Latest Headlines
See All



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