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.