Fibromyalgia - You're Not Alone!
A Community for People Touched by Fibromyalgia
The New Fibromyalgia Drugs: Hype or Hope?
Just as in 2007 with Lyrica and again in 2008 with Cymbalta, the fibromyalgia community is abuzz in anticipation of Savella, the third drug approved by the FDA for the treatment of fibromyalgia. That this news should garner such attention is not really surprising given the level of involvement and sophistication among fibromyalgia patients, but we should always remember to temper our expectations with a bit of sobriety. A little rational analysis can tell us a lot about how these drugs were developed, and what can be reasonably expected from them.
When Pfizer’s Lyrica was approved by the FDA in June of 2007 it became the first prescription medication indicated for the treatment of fibromyalgia. It’s approval represented not only a hope for better individual treatment, but also a kind of validation for the fibromyalgia community at large. After years of struggling just to be heard by the medical establishment, fibromyalgia sufferers were suddenly watching Big Pharma recognize fibromyalgia as a treatable condition.
Not surprisingly, the drug has been a big winner for Pfizer. Lyrica’s fibromyalgia sales have been brisk from the start and are expected to grow to $641 million by 2016. In light of these numbers, it is easy to understand Pfizer’s motivation in pursuing the FDA approval. They fails to explain, however, exactly what fibromyalgia patients can expect from Lyrica.
Despite the hype, the approval of Lyrica for fibromyalgia has offered little in the way of novel treatment for fibromyalgia. In fact, Lyrica already has been available in the U.S. (with a neuropathic pain indication) since 2005, and of course, doctors have always been free to prescribe for off-label uses.
So, if the drug was already available, what was gained by the FDA's approval of Lyrica for fibromyalgia? For the fibromyalgia patient, there were two main benefits. The first was that insurance companies were more likely to include Lyrica in their formularies, and the patient was less likely to be required to pay out-of-pocket for the medication. The second was that some doctors (primarily those unfamiliar with treating fibromyalgia) became more comfortable with prescribing Lyrica for fibromyalgia.
These are not small matters, to be sure, but they aren't exactly the breakthrough for which some fibromyalgia patients had hoped. In contrast, Pfizer got exactly what they desired: a regulatory license to directly market Lyrica to fibromyalgia patients.
All of the subsequent largesse was not lost on Eli Lily and Company, and in a manner similar to Pfizer, they pursued a fibromyalgia indication for one of their existing drugs (the anti-depressant, Cymbalta). Upon receiving Cymbalta's approval in June of 2008, they poured millions of dollars into a direct marketing campaign and once again sales boomed.
Both of these approvals caused quite a stir, but both were really more about market positioning for the manufacturers than about breakthroughs in fibromyalgia treatment. This is not to say these medications are ineffective. Quite the opposite, they help a number of fibromyalgia patients live better lives. It is actually somewhat intuitive to surmise that a medication originally approved for neuropathic pain and a medication originally approved for depression would be helpful in the treatment of fibromyalgia, but neither of these medications offers a true breakthrough in treatment.
This summer, Forest Pharmaceuticals plans to release Savella, the third FDA approved fibromyalgia medication. Right away, we should recognize that Savella is different from Lyrica and Cymbalta in that it is actually a new molecular entity not previously approved by the FDA for any indication.
Savella, like Cymbalta, is an anti-depressant categorized as a Serotonin-Norepinephrine Reuptake Inhibitor (SNRI). That is to say, it’s mechanism of action is the same as that of Cymbalta. Savella does differ from Cymbalta in that it is more selective for norepinephrine, while Cymbalta is more selective for serotonin. This gives reason to believe that Savella may provide a valuable alternative to Cymbalta for some patients, but we should also be aware that Savella does not represent a radical step forward in treatment.
For clarity, it is informative to examine the manner in which the FDA handled the New Drug Application (NDA) for Savella. Every NDA is classified during the drug review process according to it’s perceived importance to society. According to the FDA, "Fast Track, Accelerated Approval, and Priority Review are approaches that are intended to make therapeutically important drugs available at an earlier time.”(1)
Drugs for previously untreatable conditions or drugs with a novel mechanism of action would likely qualify for these high priority reviews. For instance, Lyrica, by virtue of being the first drug with a fibromyalgia indication, was given a Priority Review even though it was not a new molecular entity. Savella, however, was not reviewed under any of these priority classifications, but rather, under the Standard Review process which according to the FDA, “is applied to a drug that offers at most, only minor improvement over existing marketed therapies.” (2) [emphasis added]
Keeping things balanced and in perspective is important for fibromyalgia patients, so as summer approaches and the hype for Savella shifts into high gear, remember those words, minor improvement, and set your expectations accordingly.
1. US Food & Drug Administration, "Fast Track, Accelerated Approval & Priority Review," May, 2006, http://www.fda.gov/oashi/fast.html (March 20, 2009)
2. US Food & Drug Administration, "Fast Track, Accelerated Approval & Priority Review," May, 2006, http://www.fda.gov/oashi/fast.html (March 20, 2009)
When Pfizer’s Lyrica was approved by the FDA in June of 2007 it became the first prescription medication indicated for the treatment of fibromyalgia. It’s approval represented not only a hope for better individual treatment, but also a kind of validation for the fibromyalgia community at large. After years of struggling just to be heard by the medical establishment, fibromyalgia sufferers were suddenly watching Big Pharma recognize fibromyalgia as a treatable condition.
Not surprisingly, the drug has been a big winner for Pfizer. Lyrica’s fibromyalgia sales have been brisk from the start and are expected to grow to $641 million by 2016. In light of these numbers, it is easy to understand Pfizer’s motivation in pursuing the FDA approval. They fails to explain, however, exactly what fibromyalgia patients can expect from Lyrica.
Despite the hype, the approval of Lyrica for fibromyalgia has offered little in the way of novel treatment for fibromyalgia. In fact, Lyrica already has been available in the U.S. (with a neuropathic pain indication) since 2005, and of course, doctors have always been free to prescribe for off-label uses.
So, if the drug was already available, what was gained by the FDA's approval of Lyrica for fibromyalgia? For the fibromyalgia patient, there were two main benefits. The first was that insurance companies were more likely to include Lyrica in their formularies, and the patient was less likely to be required to pay out-of-pocket for the medication. The second was that some doctors (primarily those unfamiliar with treating fibromyalgia) became more comfortable with prescribing Lyrica for fibromyalgia.
These are not small matters, to be sure, but they aren't exactly the breakthrough for which some fibromyalgia patients had hoped. In contrast, Pfizer got exactly what they desired: a regulatory license to directly market Lyrica to fibromyalgia patients.
All of the subsequent largesse was not lost on Eli Lily and Company, and in a manner similar to Pfizer, they pursued a fibromyalgia indication for one of their existing drugs (the anti-depressant, Cymbalta). Upon receiving Cymbalta's approval in June of 2008, they poured millions of dollars into a direct marketing campaign and once again sales boomed.
Both of these approvals caused quite a stir, but both were really more about market positioning for the manufacturers than about breakthroughs in fibromyalgia treatment. This is not to say these medications are ineffective. Quite the opposite, they help a number of fibromyalgia patients live better lives. It is actually somewhat intuitive to surmise that a medication originally approved for neuropathic pain and a medication originally approved for depression would be helpful in the treatment of fibromyalgia, but neither of these medications offers a true breakthrough in treatment.
This summer, Forest Pharmaceuticals plans to release Savella, the third FDA approved fibromyalgia medication. Right away, we should recognize that Savella is different from Lyrica and Cymbalta in that it is actually a new molecular entity not previously approved by the FDA for any indication.
Savella, like Cymbalta, is an anti-depressant categorized as a Serotonin-Norepinephrine Reuptake Inhibitor (SNRI). That is to say, it’s mechanism of action is the same as that of Cymbalta. Savella does differ from Cymbalta in that it is more selective for norepinephrine, while Cymbalta is more selective for serotonin. This gives reason to believe that Savella may provide a valuable alternative to Cymbalta for some patients, but we should also be aware that Savella does not represent a radical step forward in treatment.
For clarity, it is informative to examine the manner in which the FDA handled the New Drug Application (NDA) for Savella. Every NDA is classified during the drug review process according to it’s perceived importance to society. According to the FDA, "Fast Track, Accelerated Approval, and Priority Review are approaches that are intended to make therapeutically important drugs available at an earlier time.”(1)
Drugs for previously untreatable conditions or drugs with a novel mechanism of action would likely qualify for these high priority reviews. For instance, Lyrica, by virtue of being the first drug with a fibromyalgia indication, was given a Priority Review even though it was not a new molecular entity. Savella, however, was not reviewed under any of these priority classifications, but rather, under the Standard Review process which according to the FDA, “is applied to a drug that offers at most, only minor improvement over existing marketed therapies.” (2) [emphasis added]
Keeping things balanced and in perspective is important for fibromyalgia patients, so as summer approaches and the hype for Savella shifts into high gear, remember those words, minor improvement, and set your expectations accordingly.
1. US Food & Drug Administration, "Fast Track, Accelerated Approval & Priority Review," May, 2006, http://www.fda.gov/oashi/fast.html (March 20, 2009)
2. US Food & Drug Administration, "Fast Track, Accelerated Approval & Priority Review," May, 2006, http://www.fda.gov/oashi/fast.html (March 20, 2009)
Add a Comment
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Comment by Larry Payton on March 30, 2009 at 5:57pm -
I can think of a few reasons why SNRI's might benefit some fibro patients.
-Recent studies have shown norepinephrine plasma levels to be depressed in some fibromyalgia patients.
-Tricyclic antidepressents, which similarly effect norepinephrine levels, have a fifty year track record of being an effective adjunct in the treatment of pain. Amitriptyline, in particular, helps a lot of fibro patients.
-Fibromyalgia and depression often overlap (30-50% of fibromyalgia patients meet the criteria for clinical depression at the time of their diagnosis), and in the treatment of depression, experience has shown that there isn't one best anti-depressant for everyone (even if we don't understand exactly why this is).
-Some of the effects of norepinephrine are increases in alertness, arousal and attention span, and it's easy to see how this might benefit fibro patients.
Like you, I would be hesitant to switch from an SSRI if it was effective, though. You would likely be tapered off your current med and then gradually increased on the new med, so you would be looking at several weeks before you would even know how it works.
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Comment by Anne Hillebrand on March 30, 2009 at 2:17pm
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For those of us who have this group of symptoms: depression, anxiety/panic, obsessive/compulsive, and procrastination, and it came with the FMS, we discovered that taking an SSRI med in the evening works.
It keeps Serotonin (our brain's chemical "signals") moving, and moving in the right direction. Taking it in the evening keeps working best during sleep, when our bodies are doing maintenance. It also doesn't interfere with daily routine.
We can take a brand name SSRI, like Paxil (or its inexpensive generic equivalent, Paroxetine, which is only $9 for 30 days at Walmart Pharmacy).
I don't know of any reason that Fibros should take an SSNRI. Do you?
Taking an SSRI/SSNRI is expensive, and from the thousands of messages I have read online and in my email box since Cymbalta it sounds like it causes problems that we don't have with the SSRIs.
If Savella is more selective for norepinephrinesaid than Cymbalta, I don't know why Fibros would want to take it.
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