[Cris5]

I feel left out that all the new drugs I hear about for IBS are for women. I mean - i'm happy for anyone who can find some relief, but does anyone know anything thats coming out for both sexes, or for guys?

 

[Kathleen M.]

I don't think we fully understand why certain drugs have gender differences, so I don't know that they can do the drug design to ensure both genders (or one or the other) will have statistically significant as a group response to any given drug.They have to test all drugs in both genders to the Phase II testing (in a few hundred sufferers to see if it does anything at the doses tested as safe in Phase I).They started doing this because they did find that a lot of drugs that worked in men (traditionally they only use men in drug tests up until the mid 1990's when the law changed) didn't work as well in woman and a few that were rejected in men only tests worked in woman.They are looking a bit at what causes the IBS drugs to be so gender specific (I know with Lotronex they did find a very small % of men did respond in some tests the same as women) but I don't know that they have a full understanding of what is causing the gender differences.I suspect that over time there will be IBS drugs that do work for both genders and/or we will figure it out enough to design drugs for men...but as I understand it we are not there yet.There are a number of drugs used for IBS that are not IBS specific (were developed for other things) that seem to work OK for men.K.

 

[trbell]

I think men are included in the trials for some of the new drugs coming out?Bada

 

[Kathleen M.]

Just like for Lotronex and Zelnorm the by law HAVE TO test the drugs in BOTH genders through PhaseI and PhaseII testing.So EVERY SINGLE drug coming up in the pipeline will initially be tested in BOTH men AND woman.Phase III testing depends on the results of the Phase II.So Phase III is only done in the genders that had benefit for Phase II...I'm not sure where all the upcoming drugs are in the pipeline.K.

 

[trbell]

i wasn't expecting you to feel like you had to answer the question, K. I thought there might be others with some information on things like dexlox and I think naltrexone is for all? I also had heard they were doing studies on lotronex and zelnorm for men now?Bada

 

[Kathleen M.]

I just wanted to clarify what "doing tests in men" might actually mean with new drugs.I've just seen too many people read stuff and assume the NEVER tested the ones on the market in any man at any time, or assume that just because Phase II tests with a new drug included men that means anything in particular....I've seen one published work on Lotronex in men that showed some men respond just like woman, but I don't know if they have followed up enough to know why. Looking at a what is scientifically interesting view I would assume there would be a fair amount of research over time about why these drugs act so differently, AND even if you are just profit-motivated you would want to see if you can figure out the why so you can use that info for developing more drugs (IBS or otherwise).K.

 

[trbell]

I can identify with Chris, i think, when I'm in pain and I see all these fancy ads flooding the media about zelnorm for women but i don't think he said anything negative about women or testing drugs for women.Bada

 

[Charlie357]

I'm a happy male Zelnorm user,so far,started in May. I always thought male and female digestive organs and intestines were the same,so the same medicines could be used for either gender. Aren't we all alike except for the reproductive organs and body size? I realize females are softer and cuddlier.