Savella's Secret? "Unknown Factor" Could Be Key To Symptom Relief
This article was originally published in Pharmaceutical Approvals Monthly
Executive Summary
The effect of Forest’s fibromyalgia therapy Savella (milnacipran) on a composite responder endpoint in Phase III did not correspond to the results for individual components of that endpoint, an "unusual finding" that the reviewing FDA division director suggested could result from the drug’s effect on an "unknown factor."
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