FDA delays decision on antidepressant milnacipran use for fibromyalgia

Milnacipran is an antidepressant that has been around since the late 1990s. The medication falls under the NSRI group of antidepressants. As with some other types of antidepressants, doctors noticed that milancipran also seemed to help patients who had fibromyalgia so a study was done a few years ago to evaluate its safety and if it was effective in treating pain and fibromyalgia symptoms, like fatigue, depression, and sleep difficulties.

Initially, the results seemed very promising and an application was made to the FDA to allow milnacipran to be used on-label (approved) for treating the symptoms of fibromyalgia. However, there was some debate among researchers as to whether the results were statistically significant – meaning, if it really made a difference.

The FDA announced last week that they were holding back on making a decision regarding an application for the fibromyalgia designation but the report did not say why. As far as we can tell, the FDA didn’t ask for any follow-up information or clarification, something that is often done.

Hopefully, more news will come out as to why they are holding back on their decision.

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Tags: chronic pain blog, pain blog, fibromyalgia, symptoms of fibromyalgia, fibromyalgia symptoms, milnacipran, milnacipran for fibromyalgia