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FDA approval of prescription drugs for Fibromyalgia seen raising awareness as well as pharma revenues

  [ 85 votes ]   [ 14 Comments ] • January 4, 2008

In the first 9 months of 2007, Pfizer, the maker of LyricaTM (generic name pregabalin - which in June 2007 became the first prescription drug to receive FDA approval specifically for treatment of Fibromyalgia) reportedly spent just under $40 million on Lyrica’s advertising. Meanwhile, worldwide sales of Lyrica increased 50% in 2007, to $1.8 billion, the New York Times reported in January. Lyrica, an anticonvulsant, has also been prescribed with FDA approval since 2005 to treat diabetic and post-shingles nerve pain and seizures.

As for the future, according to a Medical Marketing & Media news report, “New therapies are expected to grow the Fibromyalgia market from under $400 million in 2006 to $2 billion by 2016.” In addition to Lyrica, “the FDA is set to decide on Eli Lilly's CymbaltaR in Fibromyalgia on or before June 2008, while Forest Labs and Cypress filed milnacipran for that indication on December 31st [2007].* Two other compounds are in late-stage clinical development. And other hopefuls are entering the race.”

Marketing Strategies Founded On Awareness-Building

"Do you think having FDA-approved drugs will improve respect, treatment, and results for patients, or just make money for drug companies?" a patient asked FM pain researcher Dr. Daniel Clauw, MD, in his recent Live Chat Q&A on "Absolutely. Drug companies are already spending a lot of money educating physicians about FM," Dr. Clauw responded. "When physicians better understand diseases they treat them better. So I think that the drugs themselves will be of benefit, but that the education campaigns they disseminate regarding FM will be at least as helpful as the drugs. Some of the companies are also developing very good patient education and self-management programs for FM too. So I'm OK with the companies making money if they help patients." As for patient results, Dr. Clauw noted, "The data suggest that Lyrica, like the other drugs that will likely be FDA approved for FM, works well in about 30% to 40% of patients who take it."

A "Risk to Benefit Ratio"

Specifically, about 30% of patients in clinical trials said their pain improved by "at least half" vs. 15% of those taking placebos. The average improvement for all participants was 2 points on a 10-point scale, vs. 1 point for placebo. Potential side effects identified in the trials include weight gain/edema (an average 7% gain over 12 weeks in 9% of patients), dizziness, and sleepiness. But severe pain can be capacitating, and "the overall risk-to-benefit ratio" supports the drug's approval, senior FDA officials reportedly decided.

Much of the advertising for Lyrica has been direct-to-consumer on TV, websites, and magazines, the MM&M report notes. It has included unbranded “condition-awareness efforts” developed collaboratively with the National Fibromyalgia Association that feature Fibromyalgia patients speaking about their experiences, followed by initiation of branded ads that employ essentially the same messages. A strong indication that the awareness efforts are “resonating,” industry watchers say.

"What's going to happen with Fibromyalgia is going to be the exact thing that happened to depression with ProzacTM," Dr. Clauw has commented. "These are legitimate problems that need treatments."


* Cymbalta (duloxetine) is a selective serotonin and norepinephrine reuptake inhibitor (selective SNRI) that is FDA approved for treatment of major depressive disorder. The theory is that it increases the activity of these two neurotransmitters, which somehow affects “the volume of messages about pain between the body and the brain” and communication of messages affecting mood. Milnacipran is a norepinephrine serotonin reuptake inhibitor (NSRI) also studied for treatment of major depression and chronic pain. Reports in the medical literature have tracked the progress of FM trials for these and other drugs for a number of years.

Note: This information has not been evaluated by the FDA. It is generic and is not intended to prevent, diagnose, treat, or cure any disease. It is very important that you make no change in your healthcare plan without researching and discussing it in collaboration with your professional healthcare team.

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Article Comments Post a Comment

regarding RX for fibromyalgia
Posted by: tylbia
Jan 9, 2008
I do wish that what you have noted in your summary of new meds for fbromyalgia was totally accurate instead of just giving false hope. I have been on cymbalta for about a year and about three months ago started taking lyrica, up to 75 mg. 3 x per day, but had to cut it back to twice a day because the extra pill made me shaky and feeling very strange. I was concerned about nuerological harm based upon my reaction. so the information given regarding the two named meds should be qualified to state that there are some cases that just do not respond to these meds. unfortunately I am one of these.
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Posted by: greenthumb
Jan 9, 2008
I was very encouraged about trying Lyrica...especially since I have had severe reactions & allergies to many other drugs. I thought, "Finally, something for Fibro specifically." My encouragement was sidelined fairly quickly as Lyrica made me feel strange, and caused uncharacteristic severe depression (something I have never experienced), as well as weight gain. My personality changed, as well. It scared the dickens out of me.

I've found the best help so far has been to eat 100% organic, gluten-free diet, which was a surprise to me, but reducing chemical load in my food and skin/hair products has been beneficial.

Last year I was in a wheelchair a lot and using a cane. This year, not at all.


New drug for fibromyalgia
Posted by: Lukie
Jan 9, 2008
I have been taking Lyrica 50mg 3x per day for one month and it is a blessing to me. However, it is the first time I have been treated with any drug for fibromyalgia. You may still have residue in your system from the cymbalta. You may level off at some time in the future. I was diagnosed with fibro in 1995, but believe I have had a form of it many years previously. I was a professional figure skater for 12 years. I remember waking up in the morning with a great deal of pain with tears actrually running down my face! Now I feel wonderful and have felt this way from the first day I took the meds. I no longer feel tired, but instead feel 15-20 years younger. When a storm passes through I do not feel like a barometer! There are a lot of new drugs that are about to be approved, so take care and I wish you the best in your quest!!


Rx for fibromyalgia
Posted by: starstella
Jan 9, 2008
As I recall, the article did state that Lyrica was helpful in 30-40% of cases, which is a number that I do not think is very promising. My doc has not even suggested that I try Lyrica, which is fine with my based on the side effects that are cited for that drug. I'm sorry that the cymbalta did not help you. I do not like taking neurological drugs for fibro either. The one drug I was taking, it was so long ago I don't remember the name, caused a gradual onset of dizziness, especially when driving, that I had to stop the drug. It was pretty scary driving on the interstate, and having the sight of other cars in my peripheral vision causing dizziness. I used to hold on to the steering wheel so hard, trying to just look ahead to keep the dizziness down to a minimum. It upsets me that fibromites are given drugs that are not for fibro, but are prescribed because they might be helpful. The only advantage of Lyrica that I see is what the article states; the advertising of Lyrica is increasing public awareness of the condition, and other drug companies will hopefully work even harder to find a drug that will actually be directed at the fibro symptoms.


lyrica and cymbalta
Posted by: wldman46
Jan 11, 2008
beware as there may be problems for some people.Me as an example:lyrica,I gained about 10 pounds a month for the first 3 months.went from fibro fog to complete blackout people would talk to me and it was like i wasnt there.Now im told I have blood test coming back with abnormal liver function.And now for the scariest Cymbalta have family watch you when you take this one I when from normal well as normal as you can be with chronic pain to suicidal thoughts in about 1 week.Cure worse than the disease.Oh yes I didnt mention one thing about lyrica severe vision problems also within about 15 minutes i cant even read a newspaper and cant drive at night anymore glare and halos
Reply Reply

that's scary
Posted by: greenthumb
Jan 13, 2008
I hadn't heard about Cymbalta problems, but most drugs are pretty scary! I take Desyrel because my rheumatologist feels that's the most benign one out there. So far it helps me sleep and I haven't had any bad side effects...sometimes headaches. I also take Ambien; my pain levels are pretty high so even with these I don't stay asleep all night. I've had lots of problems with anti-convulsants, anti-depressants, and pain killers so I'm really trying to take a natural long-term approach. It's a little difficult because the pain is so immediate and constant, but I'm making some strides in the right direction. Thanks for the heads up.


Lyrica's effect on your eyes
Posted by: shan1078
Jan 12, 2008
Lyrica made my vision very blurry. I had to go to the eye doctor 2 times. They couldn't tell me if it was from the Lyrica or not. As soon as I quit taking the Lyrica, all of my vision came back. The doctors I saw knew nothing of a side effect that would effect my vision. I think this side effect should definately looked into.
Reply Reply

Blurry Vision
Posted by: Aberlaine
Jan 30, 2008
I find when I increase my dosage, I have blurry vision for a day or two. Then it slowly goes away. My pain has been lessened considerably. Unfortunately, I've found that when my side effects went away, so did the pain management. I was able to see clearly and my pain was back.

I hate to think that I have to keep increasing the Lyrica in order to keep my pain under control. That's unacceptable. I'm at 225 mg now. How high will I have to go?


lyrica-bad side-effects
Posted by: yellarose
Jan 12, 2008
my orthopedic dr prescibed lyrica for bursitis in my shoulder with dosage 75 mg/twice daily. it made feel strange plus swelling of feet, legs and felt like my throat was swelling. in the future make a drug without these terrible side effects and it did not reduce my deep muscle pain.
Reply Reply

for Trigeminal Neuralgia
Posted by: Svette_Palme
Jan 19, 2008
I have had Fibro for many years, but then developed Trigeminal Neuralgia also, and the doc prescribed Lyica for Trigeminal Neuralgia. I did not find that it helped much with the deep muscle pains either [as the previous poster had mentioned]. It DID help a lot with the Trigeminal Neuralgia ["TN"]. I stopped Lyrica when I resolved the TN with dental extractions. Interestingly, my deep muscle pains and twitchy/spasming muscle pains and aches were very much reduced after having the teeth removed! Others I know have also said that their pains were significantly reduced after their painful teeth were removed. I don't know it that is from infection or the contribution to general pain levels and hypersensitivity that constant dental pains might be producing.
Reply Reply

New Fibro Medications
Posted by: Squirt
Jan 28, 2008
I just now read the newsletter from Jan 4th & all the above postings & comments. Did we not read on this website over the last 18mos.research showing fibromyalgia is a neuro disorder which sends false signals from the neuro center of our body to the millions of our neurotransmitters & give us a false signal we have more pain where there is little or no pain? Simply said, but so much more complicated because our bodies are incomprehensibly complex. Each of us have differing symptoms that are going to respond in differing ways to the things we put in our bodies. What will work "miraculously" for one, may very well incapacitate another. Bottom line for me: 1) Eat nutritiously, which means not eating foods that are adulterated with things like hormones, antibiotics, high fructose corn syrup, refined sugars & salts, or MSG AND consentrate on making 75% of it all the fruits and vegetables you want (preferably fresh, raw, or steamed); 2) Do some kind of resistence strength exercise (there are so many & you can do them at home! I swim with fins & hand paddles); 3) get 6 to 8 hrs sleep per night; and 4) practice bio-feedback with positive affirmations. I do take diclophenac for pain, mirapex for RLS, and cymbalta which is helping the neuropathic pain in my feet, to stay asleep at night & keep me depression-free without feeling like a zombie. I also use a CPAP for my sleep apnea. I am 62, lost 45 lbs last year but still weigh 220, and just started resistence strength training. I am almost pain free, have lots of energy, & my goal is to be FIT/SHAPED as a size 10-12, exchanging my fat for muscle, by year end 2008. Oh, by the way, resistence strength training has been shown to REVERSE aging in older people. No miracle drugs...strength training & nutritious food. My strongest help over these 12 months has been my faith in God, letting Him take control, listening & setting a goal of being HIS servant by helping others with chronic pain to do what I am doing...retaking my body & my life! Give it a try. You have nothing bad to loose and everything good to gain. Donna in Molalla, OR
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