# MOTOFEN



## AmandaP (Jan 12, 2003)

I just today received this email from Valient. I was expecting it. Not good news.Ranette MasonValeant Pharmaceuticals North AmericaOne EnterpriseAliso Viejo, CA 92656T: 949.461.6565F: 949.461.6626E: [email protected] 4, 2010Dear Valued Customer,As you know, we at Valeant have been working diligently to reintroduce Motofen for patient use. From the first time we heard from patients about the need to make this important product available again, this has been a priority for Valeant. Bringing a product to market is a complicated process, but while there were many challenges confronting us in our effort, our focus on helping patients like you pushed us forward. Thus, it is with great regret that we have to inform you that the FDA recently ruled that Motofen can not be approved for use at this time. While this is extremely disappointing to us, we know the implications are far more significant to you as a patient continuing to suffer with your condition.Since learning of the decision from the FDA, our teams have been meeting to discuss next steps as we continue to strive to reintroduce Motofen as soon as possible. As we communicated to you our intent to reintroduce the product by the end of 2009, we felt that it was important that we communicate any advances or setbacks to you immediately.The decision by the FDA was both disappointing and unanticipated. We plan to discuss the decision with the FDA as soon as possible to understand what additional information is required in order to make this important product available to patients again.We will continue to communicate with you and work on behalf of you and other patients as we work through this process of reintroducing Motofen for patient use. We appreciate your support throughout this process and hope you continue to communicate your desire to see Motofen available for use once again.Sincerely,Janet Hammond Ryan WeldonVice President & Chief Medical Officer Vice PresidentGlobal Medical Affairs Neurology


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## BQ (May 22, 2000)

Wow.. I'd start hamemring the FDA with letters now then. Sheesh so sorry about this to all of you relying on this med. This is BEYOND frustrating I know.


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## petra (Feb 2, 2009)

am in the Uk but this seems bad news. What can we do? We are a bit behind USA in that we can't access lotronex. Me thinks we should try to band together to ensure anything that helps is available to everyone wherever they live.


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## AmandaP (Jan 12, 2003)

No matter how we band together, or how many there are of us - doubtful we can win over the FDA.


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## BQ (May 22, 2000)

Well a group that originated here got Lotronex reintroduced onto the market after the FDA had pulled it. It was called the "Lotronex Action Group" or LAG for short. ANYthing is possible...


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## AmandaP (Jan 12, 2003)

Who was the organizer for Lotronex?


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## BQ (May 22, 2000)

I don't remember but let me go see if any of those threads remain in our archives....


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## BQ (May 22, 2000)

Amanda I cannot find out in the archives. I think your best bet would be contact Jeffrey Roberts the founder. Here:http://www.ibsgroup.org/forums/index.php?showuser=265


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## Kathleen M. (Nov 16, 1999)

If you go to the Diarrhea Specific medications and go to the last few pages the mailing from the lotronex action group is archived there.http://www.ibsgroup.org/forums/index.php?s...all&st=1110Also I think there are some other threads back from those days (2001 or so) that may have some info.Jeff founded the Lotronex Action Group.


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## jmc09 (Oct 5, 2009)

I think people on here must be reading my mind as I was both googling and thinking about Motofen the last few days.According to Wikipedia it was 3 times more effective than loperamide and lomotil but not available in the UK and apparently its cost is too high for medical companies.Interestingly it mentioned that it was also used to treat excessive sweating and this was mentioned by another poster,Peggyk I think,who has had her symptoms relieved by an excessive sweating drug,Glyco Pyrrin I think.Do motofen and glycopyrrin have the same ingredients and are they an alternative?


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## AmandaP (Jan 12, 2003)

Motofen's ingredients are = Difenoxin and Atropine sulphate. I believe same ingredients for Lomotil. But, it must be a different mixture since Lomotil does not work as well as Motofen.


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## AmandaP (Jan 12, 2003)

Motofen was not expensive. I was getting it for $ 30 for a 3 month supply. If it ever comes back on the market I'm guessing the cost will be quite a bit higher. Lotronex is the one that is very expensive = $ 900 a month without insurance. And most insurances will only cover it for a few months.


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## jmc09 (Oct 5, 2009)

If Motofen wasn't that expensive I cannot understand why it was never issued in the UK.As for Lotronex,this stuff seems to work well for men as well as women according to tests so why isn't it on the Market also?Sorry,probably cost again.Although when you compare the amount of lost working days to the cost of prescribing lotronex then I'm sure it won't sound so expensive.


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## Kathleen M. (Nov 16, 1999)

Which tests did you see that said Lotronex is just as effective for men.The Phase II studies that the drug company did showed it didn't work for men (which is why men were not in the Phase III trials, since the mid 1990's you have to do testing in both genders and do an analysis) and the Phase IV (after market) showed there was a small subset of men for which responded to Lotronex like women, but not for the majority of men. We have had a few men who are responders post here, but it does seem to be a much smaller proportion of men that respond than women (and not all women respond to it but enough that you can see it above the placebo effect)So it can work for some men, but only those that respond the way women do. A lot of drugs have gender differences, just we don't know most of them because they used to only test drugs in men. Had Lotronex been developed a decade earlier it would have never made it to market as they never would have included women in the trials, IMO.FWIW on the sweating thing. Motofen has an anticholinergic antispasmodic in it (Atropine). One of the effects of all anticholinergics is to reduce sweating that is why all of them have a warning on them (Levsin, Bentyl, the ones used for overactive bladder, any other anticholinergic for any other issue) about being careful in conditions where overheating may be an issue. Some of them may have this effect more strongly than others, but it is just one of the things every single drug in that class does.ETA: Did see there are a couple of newer studies in men where they find some response, but I can't tell how many men really respond (better than placebo at least, but probably not all men just like it isn't all women who respond, either). I do not know if these new studies will ever be able to convince the regulators that any IBS drug will ever be worth approving. The FDA has been pretty clear that they will not allow any drug with any serious risk no matter how small to be approved for IBS. They do not think that any risk is acceptable. The UK seems even less likely to believe IBS requires treatment based on some of the statements from some of the groups that treat IBSers, so I wouldn't hold my breath that Lotronex is even close to being approved for either gender beyond the limited release in the USA.


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## AmandaP (Jan 12, 2003)

Active Ingredient in Lotronex: alosetron hydrochlorideInactive Ingredients in Lotronex: lactose (anhydrous), magnesium stearate, microcrystalline cellulose, pregelatinized starch. White film coat on 0.5 mg tablet contains: hypromellose, titanium dioxide, and triacetin. Blue film coat on 1 mg tablet contains: hypromellose, titanium dioxide, triacetin, and indigo carmine. You have to wonder why this pill is over $ 1000 for a one month's supply!!


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## Kathleen M. (Nov 16, 1999)

It isn't just ingredients only that determine cost. The cost of pills also has to cover the cost of research, development, and when one company buys something from another company (as Lotronex was bought from Glaxo by another company to produce).If we don't want companies to get research and development costs paid for by what they charge for the pills while they have patent protection then we would all have to pay a lot of taxes so all drug research could be federally funded and that may give the government too much control over what companies can or cannot try to develop.Someone has to pay for all the development and the required testing for safety and efficacy. Scientists cannot work for free and companies that provide chemicals for research and lab equipment will not give those away for free. Also everyone in a clinical study is paid and any medical costs from any serious side effects has to be paid for, etc.in 2001 the average cost to get a drug to where you can even sell it to anyone is $802 million http://csdd.tufts.edu/NewsEvents/NewsArticle.asp?newsid=6Hard to recoup that cost if you only charge what the ingredients cost you to make.I suspect with Lotronex the cost per pill is higher with the highly regulated and restrictive prescription program than it would be if it were regulated like anything else. If you cannot sell as many pills, each one has to cost more.


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## jmc09 (Oct 5, 2009)

Kathleen I saw a study were it said 53% of men responded positively to lotronex but this could just have been a very early trial and nothing came of it.


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## BQ (May 22, 2000)

jmc09Here is the latest from the FDA about Lotronex:http://www.fda.gov/Drugs/DrugSafety/Postma...s/ucm110450.htmThere it clearly states that it is still only for treatment of women. That page was last updated Aug 31, 2009. Perhaps you can talk to your Dr about it.


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## jmc09 (Oct 5, 2009)

Thank you for the link.I actually qualify for being prescribed Lotronex according to the checklist on every count except the most important one,I'm not a woman.


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## ISDExecutor71 (Aug 12, 2009)

Well this sucks. We have to endure countless tv commercials about penis extension and male "enhancement" products where if you read the fine print, these things arent approved by the FDA either, but we cant get an actual USEFUL drug that works approved by the commie government run FDA. We have E-coli in everything from tomatoes to cookie dough and they want to restrict use of a drug that works. Just another failed government agency that is more interested in the silver in their palm than the well being of the people who pay their salaries.Normally I wouldnt wish my condition on anyone, but in this case I think I can make an exception for the Fascist Drug Administration. Yes, this pisses me off.


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## jmc09 (Oct 5, 2009)

ISD, is your government,in you opinion,communists or fascists?This is because these descriptions are at opposite ends of the political scale.So if you add them together your goverment must fall somewhere in the middle on average.


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## AmandaP (Jan 12, 2003)

I'm thinking its probably easier (and cheaper) to buy crack on the streets than it is to buy Motofen or Lotronex from a pharmacy. Go figure?


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## jmc09 (Oct 5, 2009)

Amanda its one of the down sides of living in a capitalist society.If you have money its win,win,but if you dont you're screwed! To use a US expression despite being from the UK


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## AmandaP (Jan 12, 2003)

The people WITH money and the people WITHOUT any money live ok here. Its the MIDDLECLASSERs that get screwed, and as Al Pacino says - "You dont even get kissed first!"


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## jmc09 (Oct 5, 2009)

Amanda,people without money dont live well anywhere US or UK.If they say that they havent got money but they live well then they're liars!


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## AmandaP (Jan 12, 2003)

What I meant was, the low-income people dont have to work, pay taxes, insurances and get all medical for free. I dont know what welfare is like in the UK.


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## BQ (May 22, 2000)

This thread started about Motofen.And I think we are beginning to stray into other topics here.. so let's be careful to stick to the original topic, ok?


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## ISDExecutor71 (Aug 12, 2009)

Regardless, when the government gets bigger, the people suffer. The bigger the government the more power they grab, the more common people they ignore. This is about Motofen not being approved by the FDA for some stupid reason. If I remember correctly it was pulled off the shelves originally because it contained atropine. Supposedly for "our own protection" as any bureaucratic riddled big government will do. Fact: The drug worked for a lot of people. Period. Dot. Who in the world would abuse a drug that you would need to literally take hundreds of to get high from, when you can simply walk to any corner in the inner cities and buy anything you like for much cheaper and less hassle?


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## jmc09 (Oct 5, 2009)

ISD I expect the reason the drug was pulled was all about cost and profit.Meaning the cost of manufacture and marketing versus the cost of the drug didn't allow a big enough profit to be made,that's the way it usually is.But the propoganda given out is that it's dangerous,which it sometimes is and the Government and/or FDA do not want to put them selves at risk of being sued from somebody being killed by an overdose or chemical reaction to the drug.If people have been killed and it is because of motofen as all other causes of death have been ruled out then I can see that side of the argument.


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## AmandaP (Jan 12, 2003)

If its true about Motofen not being profitable to the manufacturers, then why wouldnt they just say they were stopping production - end of story! Why lead us on all last year by telling us that they would again begin production at end of last year? I think all meds make a profit. And if this pill in particular was not - they could have just upped the price like they have done with Lotronex. Does the FDA have a say so in the cost of the drug? Atropine is in other drugs - like Lomotil. So, even tho there has been talk about Atropine being the problem with Motofen - why hasnt Lomotil been pulled off the market too? I have two emails in to the FDA requesting more information about Motofen. I have also emailed Valeant to ask why their product is being questioned by the FDA after it has been on the market for so many years. I also asked them why they cant just tell us the truth. Gee, what a concept - the truth!


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## jmc09 (Oct 5, 2009)

I'm sorry Amanda governments just don't do the truth!


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## BQ (May 22, 2000)

Amanda I would be intersted to hear about whatever response you get from the the FDA or Valeant. So here's hoping they get back to with SOME response anyway.Again, I am so sorry this has happened.


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## AmandaP (Jan 12, 2003)

I certainly will post any responses I receive back from FDA or Valeant. But, I'm not holding my breath!


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## AmandaP (Jan 12, 2003)

I just received this email back from the FDA. I will forward it on to Valeant. But, it looks like they are playing ping pong and we wont get a real answer from either one.Thank you for writing the Division of Drug Information, in the FDA'sCenter for Drug Evaluation and Research. Unfortunately, this information regarding Motofen's drug application isproprietary and belongs to the manufacturer of the drug, so the FDA isnot able to disclose the information. You may contact ValeantPharmaceuticals directly to inquire about Motofen:http://www.valeant.com/about/contact.jsp.Best regards, Drug Information SH Division of Drug Information Center for Drug Evaluation and Research Food and Drug Administration For up-to-date drug information, follow the FDA's Division of DrugInformation on Twitter: http://twitter.com/fda_drug_info


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## BQ (May 22, 2000)

Did you see the "buck" as it was being passed between the two of them??







So sorry Amanda and everyone else impacted by this.


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## alices (Jan 23, 2010)

I haven't been to this board in years, as Lotronex solved my ibs problems, but now I'm told by my pharmasist that they've stopped mfg it. The group that got lotronex back on the market years ago was, I believe, headed by Jeff Roberts.I wish there was a way for force drug companies to continue manufacturing drugs that some <me!> people can't do w/o.


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## AmandaP (Jan 12, 2003)

I myself was taking Lotronex for the last 3-4 months and it really did cure the problem! But, the med is $$$$$$$ and I could not afford to keep buying it. But, I have NOT heard anything about Lotronex being taken off the market (again?).


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## Jeffrey Roberts (Apr 15, 1987)

Alices,Your pharmacist has been misinformed. Lotronex is *ABSOLUTELY* still marketed. Please ask your pharmacist to contact their distributor to confirm.If you have any difficulties ordering it please let me know.Jeff


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## Kathleen M. (Nov 16, 1999)

I wonder if they are mixing up that Glaxo sold it to another company. Glaxo isn't selling it anymore, but it is under the market with another company, Prometheus.http://phx.corporate-ir.net/phoenix.zhtml?...8&highlight is a press release back when the drug was acquired by a new company.


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## alices (Jan 23, 2010)

Thank you, thank you, Jeff! I have already left a message for my pharmacist to call me. Thank goodness I have insurance; I had no idea how much it was per month. That's outrageous! Thanks again.


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## AmandaP (Jan 12, 2003)

Find out if your insurance has a bottom line. I thought they would continue to pay each month - with my copayment being $ 30.00. But, on the 4th month they said I had reached my limit because the cost of Lotronex was so high.


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## ISDExecutor71 (Aug 12, 2009)

Any new info here regarding this?


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## AmandaP (Jan 12, 2003)

NONE.


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