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


Composite Endpoints In Fibromyalgia Subject Of Dueling Citizen Petitions

Executive Summary

In trying to convince FDA to take Cypress Biosciences and Forest Laboratories' fibromyalgia drug Savella (milnacipran) off the market, the advocacy group Public Citizen has set itself the difficult task of arguing the agency out of its established policy of accepting clinical trials with composite endpoints as proof of efficacy against the disease.

You may also be interested in...

Sleep Claim For Jazz Fibromyalgia Drug Falls On Lack Of Distinction

If Jazz's sodium oxybate is approved to treat fibromyalgia, it will go to market without a sleep claim to differentiate it from competitors

Office Of New Drugs Reorganization Should Better Balance Workload, FDA Says

CDER's Office of New Drugs reorganizes as rheumatology moves from analgesics to join allergy.

Whistleblower Investigation Delayed Approval Of Forest's Savella

FDA missed the user fee goal date for Forest's Savella (milnacipran) due to an investigation of late-breaking whistleblower allegations, review documents for the fibromyalgia therapy show

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