FDA approves Savella(TM) (milnacipran HCl) for Fibromyalgia


From Medical News Today, FDA Approves Fibromyalgia Drug - Savella(TM) (milnacipran HCl), A Selective Serotonin and Norepinephrine Dual Reuptake Inhibitor

"Although the exact mechanism by which Savella improves the symptoms of fibromyalgia is unknown, some researchers believe that abnormalities in certain brain neurotransmitters may be central to fibromyalgia. Savella blocks the reuptake of both norepinephrine and serotonin, with greater selectivity for the inhibition of norepinephrine reuptake in vitro (does anyone know what the term in vitro means in this context? Emphasis added by me.) . This may be the mechanism by which Savella acts to improve the symptoms of fibromyalgia."

and

"The efficacy of Savella was established in two US pivotal Phase III clinical trials involving 2,084 treated patients (1,460 Savella; 624 placebo), which showed that Savella demonstrated clinically significant improvements compared to placebo in treating fibromyalgia. The first study was 6 months in duration and the second study was 3 months in duration.

"In both studies, a greater proportion of patients in the Savella treatment arms (100 mg/day and 200 mg/day) as compared with placebo treatment, at 3 months, experienced at least a 30% reduction in pain from baseline and also rated themselves as "very much improved" or "much improved" based on the patient global assessment. In addition, a greater proportion of patients treated with Savella as compared with placebo treatment met the criteria for a treatment response as measured by concurrent improvements in pain, physical function, and patient global assessment. In both studies, some patients who rated themselves as globally "much" or "very much" improved experienced a decrease in pain as early as week 1 of treatment with a stable dose of Savella that persisted throughout these studies."

It would be nice to see some real numbers here. Like exactly what percentage of patients experienced exactly what percentage of improvement in exactly which areas? Guess it's a secret for now.


From Forbes: Cypress shares jump on FDA approval for Savella
"It is part of a class of drug called serotonin-norepinephrine reuptake inhibitors, which include antidepressants Effexor, Pristiq and Cymbalta."

And last but not least, this comment from an article in a San Diego paper, Brainstorming brings about Fibromyalgia drug, kind of says it all for me:
"Also of note, Cymbalta and Effexor (and Pristiq) are the same type of drug as Milnacipran, and they are already available in the US. Not sure why this company decided it needed to bring yet another combined SSRI/SNRI to market. Oh wait... "revenue from Savella will likely reach $781 million annually by 2012." Wow, those altruistic guys from Cypruss really tug at the heart strings!"

Comments

  1. I would caution anyone who is considering taking any drug containing Effexor to proceed with care. I know some doctors push it as a miracle drug, but I suffered terribly while taking this drug.

    My side effects were much more debilitating than the illness it was prescribed for.

    It would be nice is someone making decisions in the pharmaceutical companies had a conscious. What is wrong in the FDA? Why do they feel we need more of the same? Greed us what propelled this country to the predicament we are in right now.

    I am disappointed!

    ReplyDelete
  2. Just to let you all know...I've read the two clinical studies which got Savella indicated and Savella is WAY better and different than Cymbalta. While Savella is a SNRI all current studies suggest that norepinephrine deficits are the root cause for the symptoms associated w/ fibro. Savella is 3 times more selective to norepinephrine than serotonin...unlike Cymbalta which is 5 times more selective for serotonin than norepinephrine...which is why it has the initial indication for depression...and only later was added the indication for fibro.

    But what really got Savella approved and why it is so different than Cymbalta is because in order for patients to be considered a "responder" they had to meet 3 simultaneous response measurements, which are: 1) reduction in overall pain by >30%, 2) a rating of "very much improved" or "much improved" based on a global self assessment test and 3) a 6 point improvement in physical function on the SF-36 scale. Nearly 1/3 of all patients met all 3 critera for response...which is HUGE because when looked at individually...over 50% met the >30% pain improvement response, 78% rated themselves either "very much improved" or "much improved" and over 50% had at least a 6 point improvement in their physical function on the SF-36 scale.

    What makes Cymbalta and Lyrica difficult are the side effects...they exhasturbate the same symptoms as the Fibro disease...insomnia, fatigue, dizziness, weight gain...

    Savella's only real side effect is the nausia, which was experienced in 1/3 of the patients in the study...but the nausea disepates after 1 or 2 weeks. This drug will end up being the foundation of treating fibro.

    ReplyDelete
  3. Thanks very much for the info. Any links available to the studies you speak of?

    ReplyDelete
  4. "...does anyone know what the term in vitro means in this context?"

    In vitro means "in the glass" or test tube, as opposed to in vivo, meaning in a living organism.

    In general, in vivo results are more relevant but more difficult to measure.

    ReplyDelete
  5. I neglected to thank you for making that clear. So thank you, Larry!

    ReplyDelete
  6. I tried Savella and Cymbalta but didn't see any improvement on either. Personally, I had the exact same side effects and withdrawal symptoms from both.

    For someone just starting FMS treatment, I would highly recommend trying Suboxone for pain management. This is not a medication most doctors would even think of using and yet I feel it's probably the safest for long term pain management because it is not believed to be addicting, you don't develop a tolerance (requiring stronger and stronger doses) and you it doesn't make you feel wacky (high) because unlike other opiates, it doesn't effect dopamine and yet it's VERY effective for pain management. Again, don't assume your doctor considered this medication - it's relatively unknown and requires a one day course to prescribe. If you are wondering, Suboxone is approved for short term use to treat various addictions and has not been tested for long term pain management although it's perfectly legal for a doctor to use it off-label that way. The catch is that if you are currently using opiates, you have to be in full withdrawal symptoms before starting this medication or else it will trigger even more intense withdrawals (probably why the one day course in prescribing is required). If you are taking opiates and this scares you, I should add that within about 10 minutes of taking your first dose, the withdrawal symptoms completely go away. Of course, if you are not taking opiates you can start Suboxone right away which is why I recommend trying it for someone just starting FMS treatment.

    Also, I'd suggest taking manufacture's claims about the percentage of patients finding the medication effective with a grain of salt. There's a great article in April, 2010 issue of Fibromyalgia Network ("FDA-approval doesn't mean 'best in show') explaining why study results may not reflect your own experiences with medications. For example, they intentionally do not include people with severe symptoms in these studies because they are less likely to meet the "effective" definition following the medication treatment. I had great insurance and a doctor who would work with me to try just about anything that was even suggested to help FMS (Fibromyalgia) but none of them made much of a difference. In the end, I've learned to temper my expectations when hearing about how a medication was found to be effective for some large percentage of FMS patients. I suspect part of the problem is that everyone diagnosed with "FMS" may turn out to have different disorders and that may be why some groups respond well to a medication and other groups don't respond at all.

    Hope this helps someone...

    ReplyDelete
  7. Thanks for this info. I hadn't heard of Suboxone, but have heard of using Methadone off-label for pain. Similar to Methadone, Suboxone is labeled for use in treating opioid dependence. See http://www.rxlist.com/suboxone-drug.htm for official and info on this drug, and http://www.crazymeds.us/buprenex.html for the unofficial and always interesting info on it. Also see my post http://theiciexperience.blogspot.com/2010/02/savella-love-it-or-hate-it-we-have.html for more on Savella and my experience with it.

    ReplyDelete
  8. I've suffered with Fibromyalgia for a couple of years but was just recently diagnosed. I have been prescribed savella but I have not yet started to take the medication. I am very skeptical of starting, reasons being addiction and withdrawal symtoms which my neurologist fails to mention when writing the perscription. She accusing me of not wanting to get better. I've spoken to her about information on nonconventional treatment which she dismiss lightly. I am going out of my mind with pain and feel like I'm losing my mind but still I'm frightened of the drug. I have so many unanswered question for example, if I stop the treatment will my symptoms worsen. Im looking for answers through researh.

    ReplyDelete
  9. Dear Anonymous,

    I put everything I know about Savella in my post http://theiciexperience.blogspot.com/2010/02/savella-love-it-or-hate-it-we-have.html.

    Testimonials are not research, but I will tell you that I didn't have any problems with withdrawl from Savella.

    Also, sometimes you have to search out a Dr. who is willing to work with you on non-conventional treatments. If there's a Fibro support group in your area you could ask there for Dr. recommendations. If that's not possible, I know there are many online groups that keep lists of good Fibro Docs: fmnetnews.com and fmaware.org are two of the top ones. Good luck!

    ReplyDelete

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