Irritable Bowel Syndrome and Digestive Health Support Forum banner

MOTOFEN

7K views 42 replies 8 participants last post by  AmandaP 
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.
 
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.
 
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.
 
This is an older thread, you may not receive a response, and could be reviving an old thread. Please consider creating a new thread.
Top