Sleep Claim For Jazz Fibromyalgia Drug Falls On Lack Of Distinction
Executive Summary
If Jazz's sodium oxybate is approved to treat fibromyalgia, it will go to market without a sleep claim to differentiate it from competitors
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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.
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