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New FDA Approval of Drug

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Old 06-22-2007, 02:31 PM   #1
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New FDA Approval of Drug

Dear all,

Lyrica has just received approval (June 21, 2007) by the FDA to help treat fibromyalgia.

Take care
God Bless

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Old 06-23-2007, 12:51 PM   #2
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Re: New FDA Approval of Drug

.......just wanted to share my perspective about the new approval for Lyrica for Fibromyalgia….sorry for the rather long post, but I felt this is important information to share and hope that you will take the time to read this, especially if you are considering Lyrica.

First of all it is great that the medical world is finally paying attention to FM and showing an interest----any interest! THANK YOU PFIZER!!!!!

The June 21, 2007 FDA approval is only a new action. To be clear, Lyrica is not a new drug. The only difference is that the drug manufacturer, Pfizer, is now FDA approved to officially add FM as one of the medical conditions for ON-LABEL use of Lyrica. Lyrica has had existing FDA ON-Label approval for other conditions since 2004; i.e., diabetic neuropathy, nerve pain, and I think neuralgia. So, there is a 3 year history regarding efficacy and side-effects of Lyrica......that history includes experiences by some FM patients as a result of some adventurous pioneer physicians who have been prescribing Lyrica OFF-label for their FM patients. For those who may not be familiar with ON/ is the simple bottom line of what it means. The FDA approves drugs ON-label for clinically researched/studied/approved medical conditions. However, physicians are legally permitted to prescribe a drug for other medical conditions which is known as OFF-label prescribing; perfectly legal. However, some doctors won't/can't write OFF-label prescriptions; malpractice concerns and some insurances simply won't allow it. Prior to this recent FDA ON-label approval of Lyrica for FM, there were no drugs approved for FM every treatment option was OFF-lable....making it a real challenge for some of us to find treatment options.

However, this new FDA action is a milestone because this is the first time that I am aware of that any drug has ever been FDA approved for ON-Label treatment of FM. My excitement about this far exceeds anything to do with Lyrica itself. Actually, I have considerable concerns about Lyrica as a treatment option for me regarding not only its efficacy, but its side-effect history (more details in this post).

Before everyone rushes to their doctors on Monday requesting Lyrica, as it's pharmaceutical maker Pfizer is hoping that we all will do.......let's take a deep breath and educate ourselves.

My skepticism about Lyrica, and this particular study, comes in part because of information learned through online research. There is an interesting article that appears to be objectively written by Michael Smith on November 16, 2006. Most importantly to me, the article seems to present relevant information in a way that neither touts nor dismisses Lyrica. It allows the reader come to one's own conclusion. It subtley reports the good, the bad, and the ugly…no hype…no fear mongering. I had to read it 2 or 3 times to fully absorb what I would call the subtle uglies. According to this article, the study leading to this new FDA approval was conducted by the University of Kentucky. It was guided by 4 staff-- 3 of whom declared a "relationship" with Pfizer, the drug company that produces Lyrica. Now, I don't know what type of association constitutes a "relationship"; and, I don't know if that is good or bad---- the reader chooses what it means to you. Of course it is no secret that "this" path to approval process is how many studies are done resulting in drugs being approved. Pharmaceutical companies are common funders/underwriters of medical studies, especially when it relates to drugs that they manufacture or hope to manufacture. That does not mean there is anything wrong with the drug---it just means be aware that there is a marketing strategy at work. It concerned me that the researchers stated 40% of the original participants eventually dropped out for 3 main reasons, including side effects, lack of efficacy, and lack of follow-up, and that the researchers stated the main reasons for the drop-outs were adverse effects associated with mild or moderate dizziness (36%), somnolence (22%), sinusitis, arthralgia, and anxiety---an inference of somewhat benign side effects-----yet, on a different unrelated website, 64 other patients (some FM) self-report/post regarding their experience with Lyrica----among some of the side effects listed by patients included significant hair loss, weight gain, feeling disconnected, drugged, and/or excessively fatigued----none of which were listed by the researchers who were inteverviewed for this article. Now, maybe that oversight was because those were rare side effects---but, those side effects are things I would want to know about before deciding to try this drug. While those type of adverse side effects certainly did not constitute the majority of the posts about Lyrica on the other website, there were several posts with those complaints. Of additional interest is that the average rating of the 64 users/posters on Lyrica was a rating of 2.9 out of 5; with 5 being the level as very satisfied. Some of the reports I have read this morning say this University of Kentucky study concluded significant improvement in FM symptoms, yet one of the articles I read stated they can claim that if the level is a 30%. Now, if you are in that 30% then it is very significant in deed, but the rationale altelrnative perspective is that 70% didn't get that level of improvement.

Even though I have the stated concerns, I am still excited about this FDA approval, but for different reasons that has absolutely nothing to do with Lyrica at all. I am more thrilled about what is going to happen than about what has happened with this particular approval. This is the first step to further research to find a cause and find a specific treatment designed to treat the cause. That process will first involve a gladiator fight among the large pharmaceutical companies over market share profit potential to secure a foothold in the FM treatment options. First, there will be a feeding frenzy of competing ON-label FDA approvals for whatever existing drugs they have among their existing patented arsenals to hold their current market share. All the while there will be a secondary race of competition among them to develop an exclusively patented (aka very expensive) drug designed exclusively for the treatment of FM----something that sets them apart from their competitors; e.g., not just an existing re-labeled drug.

That is just how the process goes……..first, a pattern of medical complaints must develop. When complaints reach a high enough level information is eventually profiled into a "conditions/disorders" and maverick trials of medications which are eventually profiled ….and, then information starts to appear in medical journals and on Oprah

To date, FM remains at being classified as a “condition" or a "disorder". There simply has not been sufficient research done to determine the pathological cause of the condition. The reason the research hasn't been done is that first the pharmaceutical companies must sense there is a profittable viability. They can not invest valuable research dollars unless there is a large enough patient pool to make their investment back and make a profit----they are a business with investors; investors want profits. With Pfizer acquiring this new ON-label approval, other pharmaceuticals now risk losing….so, they have to get their current Off-label drugs approved for FM to hold their share. Hopefully, they are ready to upstage Pfizer and now find a treatment that is not just an existing relabeled drug….but a NEW one, designed specifically for FM….but that takes research to first learn what causes it

All I can say is let the competition begin fellas....let's get with it.....we can put a man on the moon....yet I am unable to work and struggling to make the day????

I pray that Lyrica will help everyone who wants to try it. But, please do your research before running out to ask your doctor for Lyrica----know some of the side effects experienced by those who have been on it. The information is all online. I sure wish I could copy weblinks to help others, but that is not permissible on this board.

All that being said, I am looking forward to reading the further experiences with this drug!!!

Last edited by jam338; 06-23-2007 at 01:26 PM.

Old 06-26-2007, 07:26 AM   #3
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Re: New FDA Approval of Drug

Thank you for the very informative review of the FDA approval of lyrica. I am presently taking 400 mg. of lyrica with not side effects. However, I also am findng no relief from my full body pain of fibromyalgia. I was a professional employed full time for may years and the pain and disabillity of this conditon as well as meralgia paresthetica forced me to leave my job. I have tried over 30 meds( including methadone, oxycontin, marinol, etc.) with no relief. The pain continues to spread and I am basically disabled now as it is in my back, knees, and feet.

I welcomed your review of the approval of this drug as I am very much interested in research.

Thanks again. I assume you also have fibro. It is a dreaded disorder and so misunderstood.
Rascal 12

Last edited by moderator2; 06-26-2007 at 01:08 PM. Reason: It is neither necessary nor allowed to discuss the posting policy - please stay on topic

Old 06-26-2007, 11:14 AM   #4
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Re: New FDA Approval of Drug

Hi (((Rascal)))---I can relate. Sorry that the Lyrica isn't helping you, but it is good that you aren't getting adverse side effects. Maybe you might not yet be on it on long enough? You didn't state how long you have been on it. You stated you are currently on 400 mg. The article I read stated that patients dose levels were adjusted to a level where they were comfortable, with the maximum dose level at 600 mg. This particular article didn't deliniate what percentage of participants were at which various levels....though I am guessing that specific information is likely online somewhere. I just haven't been interested enough yet in it to pursue research that far since at this time I am not yet considering Lyrica as a treatment option for me.

The American College of Rheumatology related article from which this data is derived was ACR: Lyrica Shows Durable Effect In Fibromyalgia, by Michael Smith, November 16, 2006. At the time of this article Lyrica had completed Phase I & II of the study. The context of the article was sourced on that data.

The specific study phase trial periods are defined and monitored by the Food and Drug Administration in accordance with the Code of Federal Regulations.
Most clinical trials are designated as phase I, II, or III, based on the type of questions that study is seeking to answer.

In Phase I clinical trials, researchers test a new drug or treatment in a small group of people (20-80) for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.

In Phase II clinical trials, the study drug or treatment is given to a larger group of people (100-300) to see if it is effective and to further evaluate its safety. [THIS SEEMS TO THE PHASE AT WHICH LYRICA HAS BEEN APPROVED...I see where there is Phase III trial for Lyrica, but the one I found was not related to FM---it was a 15 week study related to Spinal Cord Injury]

In Phase III studies, the study drug or treatment is given to large groups of people (1,000-3,000) to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.

In Phase IV studies, the post marketing studies delineate additional information including the drug's risks, benefits, and optimal use.

The article states it sourced through interviews with the research study staff members, ACR literature, and most significantly through a presentation to the American College of Rheumatologists by Leslie Crofford, M.D., the lead researcher of the Lyrica study, University of Kentucky at Lexington. One doctor unrelated to the study was interviewed for the article, Eric Ruderman, M.D., of Northwestern in Chicago.

Here is more information paraphrased from the article that might help:

Dr. Crofford, the lead researcher reprted that the study was a
6-month/ 2-phase clinical trial initially involving 1,051 participants, most of them women. On average, patients had fibromyalgia for more than 7 years w/ a pain score of 78 on a scale of 100.

FIRST PHASE OF STUDY- 6 weeks. Patients self-titrated to a dose of Lyrica at which they felt comfortable--maximum of 600 mg/day. Patients were determined as positive responders if they had at least a 50% reduction in pain scores and had stated their pain level was much improved.

At the end of that 6-week phase, 663 patients (63%) were classified as positive responders, and 566 patients went on to enter the 26-week, double-blind, placebo-controlled part of the trial. Dr. Crofford said that the roughly 40% of the original participants who didn't go on to the double-blind phase dropped out for three main reasons: they couldn't tolerate the drug, they were lost to follow-up, or they reported lack of efficacy. However, again, patients have self-reported through online message boards that there are OTHER adverse side effects such as weight gain, significant hair loss, feeling heavily sedated, etc.---things not mentioned by the researchers in this study. Now, in all fairness, maybe those effects did not develop until after the conclusion of the 26 week Phase 2 part of the trial.

Of the 566 patients who entered the controlled part of the study, 279 remained on Lyrica while 287 were switched to placebo.

The study results concluding with the researchers determining the following:

1 in 4 four placebo patients reported their pain worsened within 7 days of being switched to the Phase 2-placebo. By the end of the 26 week period 61% of the placebo patients had lost therapeutic response, compared to 32% of those getting Lyrica.

For me, there are still a lot of unanswered questions....and, those questions may have very well been answered by the researchers elsewhere beyond this particular article----or perhaps they are just elements that Phase III, Phase IV type questions....just dunno. Definitely Phase III requires a much larger test group base 1,000-3,000 patients. Phase II is only 100-300 patients, and in the case of this particular Lyrica study was 279 patients.

However, even with just the 279 patients who went on to Phase Two-26 week trial and remained on Lyrica, I still would want to know more information about the results with that target group.....

For the 279 who remained on Lyrica throughout the Phase II test period of 26 weeks:

----->How many those patients dropped out during the 26 week phase, and why???? In this article it reports only about the 40% that dropped out during the 6 weeks of Phase 1----but what about during the 26-week Phase 2? This information would be important as it relates to adverse side effects as well as effectiveness.

----->How did their pain level change????

I am sure that in the weeks/months to come that people far more adept than me will research and report on these questions and more. As all of us continue to learn more I hope we continue to report here so we can help each other learn more on this treatment option.

Last edited by jam338; 06-26-2007 at 12:04 PM.

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