Has anyone urged makers of Methadone to get FDA Approval??

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bharrod
Posts: 163
Joined: Sun Jun 10, 2007 3:51 am

Has anyone urged makers of Methadone to get FDA Approval??

Post by bharrod »

I just read an article about the makers of Methadone, they were doing research on RLS to approve a drug called something like Riperiodole (Generic for Requip) for the Treatment of RLS. So I am just wondering, has anyone opened up this Company's eyes to getting FDA or Government approval for the use of Methadone to treat RLS, so that those of us who do use Methadone for treatment, will stop getting treated unfairly for using it for RLS?
Their contact information is at the bottom of this letter, please anyone using Methadone for RLS and finding great relief like I have, please contact this company and urge them to get government approval to use this drug for treating RLS !!

-Mia


Boehringer Ingelheim Launches National Educational Initiative to Improve Awareness and Understanding of Restless Legs Syndrome (RLS)

RIDGEFIELD, Conn., July 18 /PRNewswire/ -- Restless legs syndrome (RLS) remains a common, yet often undiagnosed, neurological sensorimotor disorder, despite many years of research and increased disease recognition. To help drive understanding and disease awareness among physicians and people with RLS, Boehringer Ingelheim Pharmaceuticals, Inc. has launched an initiative to educate about the symptoms, diagnosis and treatment of RLS including a major direct-to-consumer advertising campaign. For patients and physicians there is a web-based resource available at www.rlsrest.com, providing valuable RLS educational information and tools. In addition the company has developed an RLS Simulator -- a multi-sensory experience simulating a "day in the life" of an RLS patient to help physicians better understand this complicated condition.

"The RLS Simulator may help increase physician awareness of the disturbing symptoms of RLS which is an underdiagnosed neurological sensorimotor disorder," said Professor John W. Winkelman, MD, PhD, Medical Director of the Sleep Health Center of Brigham and Women's Hospital, Boston, Massachusetts.

While RLS symptoms can vary from person to person, they are generally described as burning, crawling, tingling, or tugging sensations in the legs. The RLS Simulator was designed to mimic the symptoms that many RLS patients experience and helps physicians gain a greater appreciation for the troubling symptoms their patients experience. This is accomplished through an audio- visual first-person narrative synched with simulated RLS sensations delivered through a state-of-the-art custom-made affixed sensory boot. It is the first experiential simulator utilizing three out of the five senses to aid in the community's understanding of RLS.

"We are committed to RLS education to ensure that the physicians better understand RLS and the impact it can have on patients' lives," said Paul Fonteyne, executive vice president, Boehringer Ingelheim Pharmaceuticals, Inc. "The RLS Simulator was created to help physicians experience first-hand the symptoms and other effects of RLS. We believe this will help improve communication between physicians and their patients."

The virtual reality format of the RLS Simulator may help convey the impact RLS symptoms have on a patient's life, showing the exhaustion these symptoms can cause due to the uncontrollable urge to move the legs at night which may interfere with the ability to sleep. According to the 2007 National Sleep Foundation Sleep in America Poll, of the more than 1,000 American adult women surveyed, women who exhibited signs of RLS at least a few nights each week were significantly more likely to also experience symptoms of insomnia at least a few nights per week.

"Though more doctors today are aware of RLS, unless they suffer from the condition themselves, they don't necessarily know what it is like for their patients to live with RLS symptoms," said Sheila Connolly, a founding member of the Restless Legs Syndrome Foundation and an RLS Foundation support group facilitator.

To further educate the medical community, Boehringer Ingelheim will provide thousands of physicians with the opportunity to experience the RLS Simulator at multiple medical meetings throughout the country this year.

About the RLS Simulator

Developed by Boehringer Ingelheim, in partnership with the RJO Group, the RLS Simulator is a virtual reality sensory encounter simulating the experiences of an RLS sufferer. Designed to help physicians better understand the symptoms and impact of RLS, the RLS Simulator allows them to experience - from a first-person point of view - a typical "day in the life" of an RLS sufferer, while feeling the uncomfortable leg sensations associated with RLS. The RLS Simulator utilizes an audio-video headset and state-of-the-art custom- made boot with an inflatable lining that tightens around the participants' leg. It is intended to mimic RLS symptoms by stimulating leg and calf muscles and providing various sensory elements, like vibrations and temperature changes. The RLS Simulator is a pure simulation; that is, it does not induce restless legs syndrome symptoms or assist in a diagnosis; it merely simulates symptoms associated with RLS for educational purposes.

About Restless Legs Syndrome (RLS)

RLS is a common, yet often undiagnosed, neurological sensorimotor disorder. Up to 10 percent of U.S. adults are affected by RLS. Approximately 12 million Americans suffer from moderate to severe primary RLS. In the primary care section of the RLS Epidemiology, Symptoms, and Treatment ("REST") study, only 12.9 percent (46 out of 357) of patients consulting a physician about RLS symptoms reported being given an accurate diagnosis for RLS. Some of the more common misdiagnoses associated with RLS symptoms are impaired circulation, nocturnal leg cramps, and osteoarthritis. Patients with RLS often experience an urge to move their legs at night due to uncomfortable leg sensations that worsen during periods of rest or inactivity, often interfere with the ability to sleep, and are partially or totally relieved with movement, such as walking or stretching. Additionally, people with RLS will often have difficulty falling asleep. Approximately one-third of sufferers experience symptoms more than twice weekly causing moderate to severe distress.

Despite many years of research and increased disease recognition, RLS still remains underdiagnosed or misdiagnosed to this day. RLS may be diagnosed with positive answers to the following criteria, which were developed by participants in the RLS Diagnosis & Epidemiology workshop at the National Institutes of Health in collaboration with members of the International Restless Legs Syndrome Study Group (IRLSSG):

* Do you have an urge to move your legs, usually accompanied by uncomfortable leg sensations? * Do your symptoms begin or worsen during rest or inactivity, such as lying down or sitting? * Are your RLS symptoms partially or totally relieved by movement, such as walking or stretching? * Are your RLS symptoms worse in the evening or at night, or do they only occur in the evening and at night?

While medication isn't right for everyone, RLS can be successfully managed in some people with moderate to severe symptoms through treatment with FDA- approved medications, called dopamine agonists.

Boehringer Ingelheim Pharmaceuticals, Inc.

Boehringer Ingelheim Pharmaceuticals, Inc., based in Ridgefield, CT, is the largest U.S. subsidiary of Boehringer Ingelheim Corporation (Ridgefield, CT) and a member of the Boehringer Ingelheim group of companies.

The Boehringer Ingelheim group is one of the world's 20 leading pharmaceutical companies. Headquartered in Ingelheim, Germany, it operates globally with 137 affiliates in 47 countries and approximately 38,400 employees. Since it was founded in 1885, the family-owned company has been committed to researching, developing, manufacturing and marketing novel products of high therapeutic value for human and veterinary medicine.

In 2006, Boehringer Ingelheim posted net sales of U.S. $13.3 billion (10.6 billion euro) while spending approximately one-fifth of net sales in its largest business segment, Prescription Medicines, on research and development.

For more information, please visit http://us.boehringer-ingelheim.com.

Boehringer Ingelheim Pharmaceuticals, Inc.
CONTACT: Kate O'Connor, Public Relations of Boehringer Ingelheim
Pharmaceuticals, Inc., +1-203-791-6250,
koconno4@rdg.boehringer-ingelheim.com; or Chesha Oliver of Ketchum Public
Relations, +1-646-935-4036, Chesha.Oliver@ketchum.com, for Boehringer
Ingelheim Pharmaceuticals, Inc.

Web site: http://www.rlsrest.com/
http://us.boehringer-ingelheim.com/

Neco
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Post by Neco »

Your heart is in the right place, but this is very VERY gray territory..

One reason people may not want to seek approval for their drugs if they are already approved for something else, is it is an expensive process and can take years.

Also, methadone is a very special case. This drug does a good job, it lasts a long time, but it is often dangerous to the general population that have 0 tolerance to opiates.

Methadone is VERY powerful, and I have even seen literature suggesting it should never even be considered for opiate-naive patients. It's why we see those kids in the newspaper etc that have overdosed and killed themselves, and their parents flip out and go psycho trying to ban it. Same for people who shouldn't have been taking it but were given it anyway, or just happened to suffer from a tragic accident or drug interaction.. People go ballastic.

It's not like saying, oh let's approve Tylenol #3, which many people consider a toothless bear. I'm not trying to rain on your parade, because I also went through this phase that you seem to be going through right now; However this is about perception of the public. Methadone has a HUGE stigma as we all very well know, not just within the medical community but also in general. Painkillers as a whole have a bit of baggage attached to them and have for decades, although it is a little more subtle compared to one drug in particular.

In a nutshell, I'm trying to say it would be an expensive, explosive subject on all fronts, and the drugmakers probably see no financial gain in doing it, so they won't do it..

Instead we have to work on educating the medical community and furthering the cause and acceptance of off-label uses for many of the prescription medications we use to treat RLS.


Also, since the company is already considering another generic, they again have no need to spend even more money (we're talking millions here) when they already have a drug with a proven track record to consider.

bharrod
Posts: 163
Joined: Sun Jun 10, 2007 3:51 am

Post by bharrod »

I spoke to my pharmacist last night and another pharmacist a few weeks ago about methadone,and both of them told me that in their opinion Methadone was no more dangerous then tylenol if taken correctly.



Zach wrote:Your heart is in the right place, but this is very VERY gray territory..

One reason people may not want to seek approval for their drugs if they are already approved for something else, is it is an expensive process and can take years.

Also, methadone is a very special case. This drug does a good job, it lasts a long time, but it is often dangerous to the general population that have 0 tolerance to opiates.

Methadone is VERY powerful, and I have even seen literature suggesting it should never even be considered for opiate-naive patients. It's why we see those kids in the newspaper etc that have overdosed and killed themselves, and their parents flip out and go psycho trying to ban it. Same for people who shouldn't have been taking it but were given it anyway, or just happened to suffer from a tragic accident or drug interaction.. People go ballastic.

It's not like saying, oh let's approve Tylenol #3, which many people consider a toothless bear. I'm not trying to rain on your parade, because I also went through this phase that you seem to be going through right now; However this is about perception of the public. Methadone has a HUGE stigma as we all very well know, not just within the medical community but also in general. Painkillers as a whole have a bit of baggage attached to them and have for decades, although it is a little more subtle compared to one drug in particular.

In a nutshell, I'm trying to say it would be an expensive, explosive subject on all fronts, and the drugmakers probably see no financial gain in doing it, so they won't do it..

Instead we have to work on educating the medical community and furthering the cause and acceptance of off-label uses for many of the prescription medications we use to treat RLS.


Also, since the company is already considering another generic, they again have no need to spend even more money (we're talking millions here) when they already have a drug with a proven track record to consider.

ViewsAskew
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Post by ViewsAskew »

Good points all around. And, Mia, for every person you find with that opinion (my old doctor would have agreed), you'll find two who feel that it's as bad as heroine. It's a drug that causes huge emotional responses to it. Since I wasn't aware of all the problems, to me it was just a drug that could help me. But, to other people, it's much more than that.

I think there is one more aspect that makes it unlikely. That is the pay-off at the end. Methadone is generic now. The makers won't win if they push for this. They would spend LOTS of money as Zach has pointed out and then they wouldn't even reap the benefits because the doctors could prescribe the generic. That's why the makes of Requip pushed so hard to get it approved quickly; they knew they were losing their sole rights to make it in a few years and needed to cash in and recover the millions they spent getting it approved.

Now, if the makers of Methadone could slightly reformulate and make a new drug that was specifically targeted for RLS...that might be different. New name, no baggage (based on name recognition, even if the formulation was similar), and many years of being able to sell it without competition...
Ann - Take what you need, leave the rest

Managing Your RLS

Opinions presented by Discussion Board Moderators are personal in nature and do not, in any way, represent the opinion of the RLS Foundation, and are not medical advice.

bharrod
Posts: 163
Joined: Sun Jun 10, 2007 3:51 am

Post by bharrod »

I also found out today that the makers of Methadone, are also the makers of Ropinirole, which is ironically the generic form of Requip.



ViewsAskew wrote:Good points all around. And, Mia, for every person you find with that opinion (my old doctor would have agreed), you'll find two who feel that it's as bad as heroine. It's a drug that causes huge emotional responses to it. Since I wasn't aware of all the problems, to me it was just a drug that could help me. But, to other people, it's much more than that.

I think there is one more aspect that makes it unlikely. That is the pay-off at the end. Methadone is generic now. The makers won't win if they push for this. They would spend LOTS of money as Zach has pointed out and then they wouldn't even reap the benefits because the doctors could prescribe the generic. That's why the makes of Requip pushed so hard to get it approved quickly; they knew they were losing their sole rights to make it in a few years and needed to cash in and recover the millions they spent getting it approved.

Now, if the makers of Methadone could slightly reformulate and make a new drug that was specifically targeted for RLS...that might be different. New name, no baggage (based on name recognition, even if the formulation was similar), and many years of being able to sell it without competition...

ed2008
Posts: 42
Joined: Tue Jul 01, 2008 11:06 pm

Post by ed2008 »

while this looks good from a medical education standpoint, i guess my years in the field have left me somewhat jaded when drug companies do these things.

Boehringer Ingelheim distributes Mirapex. the original patent has expired, but BI has a "dual patent" with the second patent not expiring until 2011... i think http://www.orangebookblog.com/2008/07/i ... rapex.html

since there is a possibility that mirapex will have a generic equivalent soon, BI (and other drug companies alike) will do everything possible to hold market share of their product. while there may not be a mention of using BRAND NAME only mirapex now, this could change with a mere keystoke.

while I hesitate to discuss methadone, i will make the following general statement. getting a drug approved for a new indication is an expensive proposition. studies, FDA fees, lawyer fees, etc are more than most generic manufacturers are willing to absorb. once a drug has gone generic, it's just not realistic to expect that additional indications will be added.

Ed

bharrod
Posts: 163
Joined: Sun Jun 10, 2007 3:51 am

Post by bharrod »

Is Methadone generic?

ed2008 wrote:while this looks good from a medical education standpoint, i guess my years in the field have left me somewhat jaded when drug companies do these things.

Boehringer Ingelheim distributes Mirapex. the original patent has expired, but BI has a "dual patent" with the second patent not expiring until 2011... i think http://www.orangebookblog.com/2008/07/i ... rapex.html

since there is a possibility that mirapex will have a generic equivalent soon, BI (and other drug companies alike) will do everything possible to hold market share of their product. while there may not be a mention of using BRAND NAME only mirapex now, this could change with a mere keystoke.

while I hesitate to discuss methadone, i will make the following general statement. getting a drug approved for a new indication is an expensive proposition. studies, FDA fees, lawyer fees, etc are more than most generic manufacturers are willing to absorb. once a drug has gone generic, it's just not realistic to expect that additional indications will be added.

Ed

ed2008
Posts: 42
Joined: Tue Jul 01, 2008 11:06 pm

Post by ed2008 »

[quote="bharrod"]Is Methadone generic?

+++++++++++++++++++++++++++++++++++++++++++++++

mia,

yes, methadone is generic. the brand name was dolophine, and i believe it was Lilly originally, dating back to 1947

Mallinckrodt makes methadose, but also provides methadone in bulk form for other manufacturers

this information came from Wikipedia.

Ed

Neco
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Post by Neco »

re: methadone is no more dangerous than Tylenol.. If you are speaking in terms of people with extensive exposure to opiates, then yes I would agree.. But for most of the population who is opiod naive, I think that is a foolish statement for a pharmacist to make.

I'll reiterate again, all these whack jobs posting on sites trying to get it banned who think it is the devil, the most evil thing out there, they are usually associated with those kinds of cases where a loved one had very little tolerance to opiates or no tolerance, and were either given a prescription they shouldn't have had in the first place, didn't understand the directions and/or took more than they should have in a short time, or they were some kid thinking he was gonna get high and have a party, not realizing what they were getting into..

Those of us here who have been on methadone for a while don't have to worry too much, a substantial increase wouldn't put much of a dent in us at all, but for the first time users/patients who are either prescribed too much, or don't think its working and take extra, abuse it, whatever.. It is a very dangerous drug.

It is true that all drugs are dangerous when not used as prescribed, however the data about accidental methadone overdoses is out there and I just feel that extra caution is extremely warranted when prescribing the drug.. I had to fight very hard to get it, as my doctor had never prescribed it or heard of it being used to treat RLS, and I got lucky. He was extremely hesistant because he had no experience with it, I mean if I were a doctor I wouldn't want to kill my patient or have some other mishap either.

Methadone is powerful stuff. Period. Back before I gave up my control to my dad, my mom used to constantly ask me what was up with my breathing when I was standing there in the kitchen smoking or whatever. I had no idea what she kept bitching about until she pointed out how loudly I was breathing, etc.. I felt fine of course, but once it was pointed out I could clearly see the labored breathing and amount of extra work that my body was doing. It wasn't scary to me but it made me stop and think. I assumed if I had severe respiratory depression starting to take effect I would at least notice it, but it can come on so subtly.. Many people who have died simply took their medicine and went to sleep..

I've only ever gone as high as about 40mg too, which is food for thought. So yes while it is a great drug and it works wonders, I still retain a certain amount of respect for it and always advocate that it NEVER be used as a front line RLS drug, especially in an opiate naive patient. I guess I feel like it is just common sense, and that's just my opinion. Methadone should truly only be used as a last resort in my eyes, because there ARE intrinsic risks involved and it is such a powerful drug.

I'm all for doctor awareness and acceptance as everyone knows, but I suppose my situation and real life experiences with opiates has given me a rather personal perspective more conservative than most.

bharrod
Posts: 163
Joined: Sun Jun 10, 2007 3:51 am

Post by bharrod »

Zack, no worries, I agree with you, it is a very dangerous drug.

It has been a huge lifesaver for me, and I do think there should be strict warnings on this drug, especially for those who are opiate naive (as I am). Had it not been for you and Aiken, I might have actually taken all 3 Methadones (instead of just taking one) and God only knows what would have happened to me taking that much methadone.

I just found out yesterday that I have full blown asthma. I'm not sure though if the methadone has affected me or my breathing at all, but still I do agree it can be a dangerous drug, but again, if taken correctly I think it can also be a very safe and effective treatment for RLS.

Now, those who do not experience worsening of their RLS or augmentation while on Requip or Mirapex may very well be better off taking those, but for me, the Parkinson's type drugs also caused severe depression and many other side effects that I could not handle. I was damn near suicidal while taking Requip, so I hate Requip and would never recommend it over Methadone, but again that was just my own personal experience with Requip.

So I guess it's a personal choice, lately the only side effect I think that methadone may have for me is sometimes I think I am more tired than I should be.

But that could be the asthma and the fact that I am working at half my lung capacity right now, so I guess it's good I quit smoking cigarettes a few months ago. LOL

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