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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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Composite Endpoints In Fibromyalgia Subject Of Dueling Citizen Petitions

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.

Composite Endpoints In Fibromyalgia Subject Of Dueling Citizen Petitions

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.

After Negative FDA Committee Vote, Jazz Has Few Notes To Play Beyond Fibromyalgia

Jazz's reformulation of sodium oxybate for fibromyalgia ran into advisory committee skepticism last week, but at least one analyst predicts FDA will override the 20-2 negative vote.

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