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Pregabalin

Posted by john h on 5/04/04 at 12:23 (150001)

Today I participated in a small research study to be used on a new drug to be on the market in the comming year. I did not take any of the drug but spent about an hour answering questions and having a Neurologist examine me.

The drug is produced by Pfzer and is named Pregabalin. It will have a wide use in treatment of pain in Firbro, various nerve pains, even anxiety and depression uses. The Doctor told me he had used it with a nuber of patients with chronic back pain in his studies and it stopped the pain dead in its tracks. They were upset when the study ended. It is not addictive and suppossedly does not make you drowsy. It would seem that this drug might well be useful with PF and TTS.

If you do a search under Pregabalin you will find a lot of interesting information. I will sure be in line when it hits the market Below is just one of many sites with information on this forthcoming new drug.

http://www.drugdevelopment-technology.com/projects/pregabalin/

Re: Pregabalin

BrianG on 5/04/04 at 12:56 (150005)

Hi John,

I read the article. It looks like this will be a replacement for Neurontin, which is used primarily for nerve type pain (when it's prescribed for pain). I don't anticipate this helping PF too much, although it may be good for TTS. Do you have both, or just PF?

Regards,
BrianG

Re: Pregabalin

Pauline on 5/04/04 at 13:10 (150006)

John,
Interesting post especially the forthcoming of a new main medication that is nonaddictive and nondrowsy.

Today I heard something on CSpan that I'd really like to check into. I heard that most of the drug companies use only a small percentage of the profit earned from their medications to develop new ones. The major percentage of money is spend to produce medications which have had their patent run out.

Right now I don't know how true this statement is, but it's very disappointing because there are lots of people with medical conditions
waiting for new drugs with hope that they would cure their condition, or eliminate side affects of older medications.

So I guess when we are told their profits are going for research most of it could be going to make a generic viagra or some other generic drug of which there may already be several versions.

I know this must be true with some antibiotics because when I get one filled it seems I always get a different brand unless the doctor writes DAW with the name brand on the RX.

For women only: Personally I'm beginning to feel we'd see a lot more progress made to help women's health conditions if the drug also happened to treated anything involving male 'parts'. They seem to run to cure anything male while we wait and hope there is a cure before we get the disease.

Maybe that would be a good discussion for the social board.

Re: Pregabalin

john h on 5/04/04 at 14:12 (150014)

Pauline I saw the CEO of Merck on TV this week discussing some of these issues. Currently we have hardly any new anti biotics in the pipe line and because of over use largely fueled by patient demand on the Doctors our current anti biotics are rapidly becoming resistant. It take nearly 15 year to bring a new drug to market because of research,testing and FDA requirements. As you know stock holders drive companies for profits and provide the money for research. You cannot expect a Stock Company to pump all their profits into research when the owners demand dividends. That is the way the American system works. Currently the Congress is looking into funding research from public funds to some extent which makes some sense as companies and stock holders expect to make a profit as they are not non profit organizations. It can cost hundreds of millions of dollars to bring a new drug to market and then under current law the patient can expire in ? years and the company can no longer recover it's investment. Another approach is to let the drug companies keep their patents longer. Some of the large companies like Merck can and do pump a lot of money back into research but most of the small one cannot afford the cost and their are more small companies than big one. We as consumers want our cake and eat it to. We do not like the high price of drugs, want the patients on drugs to expire sooner so cheap alternatives can cut out the developer, want the drug companies to pay for all research, abuse drugs like anti biotics to the point they are becoming resistant, do not care that the stock holders are getting dividends on thier investments,etc. they also discussed such drugs as Viagra. Unfortunately like most things in our economy companies go where the profit is and what the customers demand. Viagra I think is number 2 behind Lipitor as the top selling drug...

Re: Pregabalin

john h on 5/04/04 at 14:17 (150015)

Brian it is much more than Neurotin and much stronger. It can be used for epilepsy,anxiety,depression,back pain,fibromylgia,many various types of nerve pain and much more. Non habit forming and does not make you drowsy. The Doctor I talked with is part of the team doing the research and has seen first hand what it can do for patients and he is really excited. He is not an employee of Pfizer so he is speaking as a Doctor. It acts in a different manner than Neurotin and think I read it is 5-10 times more effective. Many of our foot pain problems are nerve problems so it very well may help PF. The cup is half full Brian.

Re: Pregabalin

Pauline on 5/04/04 at 14:58 (150017)

John,
But do you think there is really a need for seven genertic forms of Ethromyocin or any other drug where the patent ran out.

Why not 3 and let the others do something else?

You're right about the antiobiotics, but Viagra certainly made it to the market quickly yet we haven't seen such speed in anything in women's medicine.

The treatment provided for women always seem to lag behind. It's just recently that they determined that women's heart conditions present with differently and that they need perhaps more attention and examination
when they visit the doctor instead of the usual brush off.

A lot of times women are told their symptoms are nothing or in their heads, but I've never heard a man complain that he was told his problem was in his head.

Don't get me started. The CSpan tidbit really hit a sore spot with me.

They implant seeds into mens prostates but they haven't developed a similar treatment for women's breasts. Not as important in someone mind maybe.

It certainly would be interesting to see just how and who determines the division of money for research and the reasons behind their thinking.

Re: Pregabalin

Pauline on 5/04/04 at 15:01 (150018)

John will you be actually taking the medication as part of the study?

Re: Pregabalin

JudyB on 5/04/04 at 16:39 (150027)

If it's a double blind study, then he will not know, neither will his doctor. However I beleive Pfizer is done with the studies and is just waiting for FDA approval.

Pregabalin is poised to be the next blockbuster drug for Pfizer for those with nerve pain.

Re: Pregabalin

JudyB on 5/04/04 at 16:41 (150028)

90% of new drugs do not make it to market. It's very expensive to produce and market new drugs, esp after all the low hanging fruit has been picked.

Re: Pregabalin

JudyB on 5/04/04 at 16:45 (150030)

Pauline,
I doubt someone alone decides how the R&D budget is sliced up and used. I'm sure it's a very complex formula for the drug companies.

Re: Pregabalin

Dorothy on 5/04/04 at 16:46 (150031)

Pauline ~ You have actually indirectly hit on a sore spot with me: breast cancer. It is far from being the #1 killer of women, yet everything is pink-ribboned as if this is the primary form of disease among women. In fact, as you no doubt know, the #1 disease among women is heart disease.
Just as you indicate with women's health issues, this too has been distorted - and I think it is because it is about breasts. It is completely telling that women are, in most places, not to breastfeed their children in public (even when covered up!), the primary function of the breast, while the exposure of female breasts with sexual connotations (movies, other images) has become common. Likewise, the actual disease killer of women is ignored - and women presenting with symptoms to ERs are sent home, untreated! - but breast disease gets nationwide 'charity' benefits, pink ribbons on clothing, etc etc. And WOMEN cooperate with this lie!
Not only is heart disease the #1 killer, but many more women live in daily pain and disability with other diseases far more debilitating than breast cancer (arthritis, for one example). RIDICULOUS!

Re: Pregabalin

john h on 5/04/04 at 19:26 (150036)

Pauline: No I will not be taking any drugs in the study. I think my part is to help develop a checklist for family Doctors on who to send to specialist such as Neuroligist who might know how to better prescribe the drug.

Re: Pregabalin

john h on 5/04/04 at 19:29 (150037)

Pauline: As you must know they have a woman's verison of Viagra. If the various drug companies think they can make a profit on a verison of a drug they will market it. How many makers of aspirin do we have? I like St Joseph's Aspirin strategy. The only one they make is the 87mg aspirin you use for heart and strok prevention. That is the way they now advertise it.

Re: Pregabalin

john h on 5/04/04 at 21:48 (150043)

I think more men die from prostate cancer than women die from breast cancer. Actually, there is no good cancer. All are bad especially if you have it.

Re: Pregabalin

Dorothy on 5/04/04 at 22:09 (150044)

You are right, john h, on both points.

Re: Pregabalin

Dorothy on 5/04/04 at 22:12 (150046)

This is very interesting information, john h.

Re: Pregabalin

Dorothy on 5/04/04 at 22:26 (150050)

John H ~ I have a question that maybe you or someone else knows something about. While reading about this drug that you wrote about, I read this:
'Developed by Pfizer, pregabalin is a 3-substituted analogue of gamma-amino butyric acid (GABA) and a compound related to Pfizer's hugely successful antiepileptic drug gabapentin....'

If pregabalin is an analogue of GABA and if they are related to gabapentin which is Neurontin and if Neurontin and Pregabalin both help with nerve pain - then would taking GABA itself help with nerve pain??

I know that GABA is available OTC and is used by bodybuilders; that's the extent of my off the cuff 'knowledge' about it. Any thoughts?

Re: Pregabalin

Ed Davis, DPM on 5/04/04 at 22:41 (150054)

John:
I did a search on 'pregabalin.' Tht first site that came up was a bunch of trial attorneys looking for clients who could have ben 'hurt' by the drug. Holy smokes -- we hardly know much about this yet!
Ed

Re: RE: Drug studies specifically for women

Kathy G on 5/05/04 at 10:19 (150073)

It was pointed out to me that there aren't as many studies done on women specifically because they are women and they run the risk of getting pregnant. While studies on men could conceivably bring about genetic changes to their sperm, it is highly unlikely. Women are considered to be of child-bearing age up to at least forty-five, and thus, any testing done on them prior to that age has to be conservative, with no risk to a fetus. As many can attest, no birth control method is infallible and drug companies don't want to force women to have to make a choice about aborting a pregnancy should they become pregnant while taking an experimental drug.

Certainly, several years ago, all of society, not just the medical, was geared much more toward men but that has changed greatly over the last thirty or forty years. And drug companies know that women represent half of their customer base. If they could, they'd have just as many specialty drugs for women as they do for men.

As to the prime killer of women being heart disease, I believe that most women are aware of that. I think all women still fear breast cancer the most, mainly because they know someone who has had it, and the ramifications terrify them.

As for Viagra, I believe that both men and women benefit equally from the drug. No couple should have to go without a sex life if they can be helped. This drug is extraordinary and it has revived the sex life of many people who suffer from diseases such as diabetes and high blood pressure; conditions that require drug treatment that causes impotence. And no, I don't own any drug stock or know Mike Ditka personally!

Sorry; I think this discussion probably belongs on the Social Board but I wanted to get in my two-cents worth!

Re: Pregabalin

JudyB on 5/05/04 at 12:20 (150079)

April 29, 2004 6:22 PM GMT (Datamonitor) - A new study presented at the American Academy of Neurology annual meeting demonstrated that Eli Lilly's [LLY] selective serotonin norepinephrine reuptake inhibitor duloxetine significantly reduced diabetic neuropathic pain. The study highlights the possibility of further commercial opportunities for Lilly's drug.

The 12-week randomized multi-center double-blind study, involving 334 patients with diabetic neuropathy, assessed the efficacy of duloxetine (60mg once or twice daily) compared to placebo at reducing pain associated with diabetic neuropathic pain (DNP). The results of the study showed patients treated with duloxetine reported significant reductions in pain, compared with those taking placebo, after one week of active therapy. The data supported those of earlier studies in which duloxetine (60mg once or twice daily) significantly reduced diabetic neuropathic pain versus placebo.

Diabetic neuropathy is a nerve disorder caused by chronic hyperglycemia and is normally characterized by the loss or reduction of sensation in the feet and sometimes hands, together with weakness and pain. DNP is a major medical problem affecting over 3.7 million patients in the US alone and placing a substantial burden on the diabetic population.

At present, no drug is approved for the treatment of DNP and therefore a major commercial opportunity exists for any company that can gain approval. Such opportunities are demonstrated by Pfizer's [PFE] anticonvulsant, Neurontin (gabapentin), which is already widely prescribed off-label and has generated considerable sales from DNP prescriptions. Not surprisingly, several of the leading pharmaceutical companies are battling to be first-to-market.

This recent study is good news for Lilly's duloxetine, which is currently in Phase III trials for neuropathic pain. However, Lilly will face strong competition. Gabapentin, soon to be off patent in the US, will create one of the biggest barriers to Lilly's duloxetine achieving DNP market penetration. Furthermore, Pfizer's follow-up compound to gabapentin, pregabalin, is expected to launch in 2004, creating further competition.

Nonetheless, the results create potential opportunities for further label extensions for duloxetine, which is expected to burst onto the antidepressant and urinary incontinence markets during 2004. Moreover, once the drug launches, the positive trial data may help the company generate sales from off-label use, especially in the US.

Re: Pregabalin

john h on 5/06/04 at 11:13 (150126)

Ed the lawyers are always lurking in the bushes. The drug is not even on the market and probably largely because the trial lawyers make it so hard to bring it to market. I wonder how many makers of Aspirin get sued each year? Or those dangerous people at Macdonalds and the real 'hot' coffee. Just a shot in the dark but I bet the Trial Lawyers add at least 25% to the cost of a drug. They probably add more than that to our medical and hospital bills. The big battle raging at the moment is the Asbestos bill before Congress. The manufactures of Asbestos or former ones are wanting to establish a large multi billion dollar fund whereby someone injured or supposedly injured by asbestos can be awarded damages without going through a lengthy trials and years of waiting. The layers of course want to sue for all they can get and take their 1/3 or more. Amazingly people who who at sometime worked around asbestos but are not sick or even have any symptoms are suing and winning large awards. Unbelievable. Any one in the Navy and was on a ship during WWII was exposed to asbestos. I have had a few building razed in the last few years and the first thing we have to do is have an asbestos abatement team come in and clear out any asbestos. I put down new tile in my kitchen a few years ago and had to place the new tile over the old tile as it was asbestos. If you pull up old tile with asbestos it fills the air with the particles and is much safer and much less expensive than have an asbestos abatement team remove it.

Re: Pregabalin

john h on 5/06/04 at 11:21 (150129)

Dorothy I do not have a clue. Some of what I have read indicates the new drug is 5 times more effective than Neurotin and does not have the side effects. It can be used for many more problems not just nerve pain. Since many people with chronic pain experience anxiety and/or depression they have found this drug to also be effect in treating these problems. There are some anti seizure druss now that are very effective in treating anxiety. Drugs such as Clonazepam (Klonpin). This new drug is also an anti seizure drug. This might be a good time to buy some Pfizer stock as I suspect this will be the hottest drug on the market next year. Any drug with the name GABAPENTIN has to be good for something. Mix this baby with Viagra and you are good to go. Be interested to see what the price will be?

Re: Pregabalin

john h on 5/06/04 at 11:31 (150130)

Aside from heart disease colon cancer may cause more deaths than breast cancer in women. Not being a woman I cannot get into the thinking that a woman with breast cancer goes through. I would guess it has much to do with how one perceives herself and self image. Many women go through some what looks like to me some really tough and dangerous procedures to improve self image. Face lifts, breast augmentation, etc. After watching some of these procedures on TV there is no way I would let someone carve on my face. If I look like Jack Palance then so be it. Men do not appear to be as image concious as women for reasons unknown to me. My wife had a breast removed and it did not bother her in the least as far as image goes and it did not bother me. Perhaps if she had been in her 30's or 40's it may have been different. Our society seems to be obsessed with breast often to the detriment of women's health.