Savella, Third FDA-Approved Fibro Drug, To Be Released Earlier Than Planned

Fibromites will have a third FDA-approved choice next week, earlier than anticipated. Savella(tm), the new drug, is produced and licensed by Forest Laboratories, Inc., and Cypress Bioscience, Inc. Originally scheduled for release in March, following a January 2009 approval decision, the manufacturers went back to the drawing board for what was described as a minor cosmetic change (i.e., they didn’t like the way the pill looked). That change also had to receive FDA approval, and release was anticipated sometime in the middle of the year.

But the approval came more quickly than expected, and shipment of Savella is scheduled to begin this Friday, with availability in pharmacies as early as next Monday, April 28, 2009.

About Savella

Savella is the tradename for milnacipran HCl. It’s classified as a selective serotonin and norepinephrine dual reuptake inhibitor; both neurotransmitters are believed to play some part in the biochemical dance that becomes our fibromyalgia symptoms.

Safety Concerns

As milnacipran is similar to antidepressants and other medications prescribed for psychiatric disorders, there is some concern over an increase in suicidal thoughts, especially in individuals under the age of 24. Contraindications include simultaneous MAOI use (or use within a 14-day period following the last dose of the MAOI) and patients with uncontrolled narrow-angle glaucoma.

Another Times Article?

Is perhaps now a good time for another NY Times article taking back all the crap about this being a “real” disease? How many drugs do you need on the market to establish that this is not some modern-day hysteria (I’m looking at you, Elaine Showalter) or BS need for attention?

Of course, the unbeliever responds: “No number of medications will convince us, because all it means is that there are a lot of you out there deluding yourselves, and the pharmaceutical companies don’t care where their bucks come from.” All right, that’s fair enough, I suppose. But here’s my question: what on earth gives you the right to decide that anyone else’s pain is not “real” in the first place?

Nobody (well, nobody sane) thinks a cancer’s patient isn’t real. Yet, until the X-ray and later the MRI and PET scan technologies were commonplace, no one could “see” the cancerous cause of the pain inside the body — at least, not until the autopsy. And yet, with fibromyalgia and CFS, we have a whole host of otherwise intelligent, educated men and women ready to dismiss the reports of thousands of other intelligent, educated men and women simply because … why, again? You can’t “see” a cause?

You mean you can’t see a cause yet.

And even that’s not the whole truth, for of course there are observable, measurable differences in the fibromyalgia patient’s biochemistry.

But, no. We’re the cranks. We’re the crackpots. We’re the ones who need attention. Frankly, I think it’s quite the other way around. I think the unbelievers are the ones who are a little unbalanced — or at the very least, incapable of rational thought — and greatly in need of some attention. I think that’s why they go against the great majority of doctors and researchers who understand the quite simple truth: that even when we don’t understand a disease’s origins, cause, or mechanisms, the fact of our lack of understanding has nothing to do with whether the disease exists.

In other words: just because you don’t understand fibromyalgia thoroughly, it doesn’t mean fibromyalgia isn’t real.

Other Resources

More information on Savella from the manufacturer

Here’s another article on Suite101 about Savella.

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