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Cilansetron likely delayed

2762 Views 19 Replies 6 Participants Last post by  jjohnson
I hate to be the bearer of bad news, but I'm afraid it may be true. I first suspected that something may be amiss when I checked Solvay's press office website and noticed that the company's stock had fallen farther and faster than I had even seen it. (And I check the site frequently.) Then I looked on that Solvay employee post I mentioned on another thread, and it said that a "launch meeting" has been pushed back to August. Whatever is going on is clearly not a secret to the company's employees or stockholders, and the company will undoubtedly be forced to make some public statement about this soon. Right now it may be hard to say how, when, or under what restrictions this drug will be approved. (I admit I am in a state of denial about "if" it will be approved.) I am very worried. I hope this is all a mistake but I wouldn't count on it. I would advise anyone who like myself was hoping to get their hands on this drug soon to make plans to try other things in the meantime. I am seeing a doctor on Monday and will ask him for Remeron. I am sorry and there is no way to sugar-coat this horrible news but I thought people would want to know.
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JJOHNSON, what does Remeron do for IBS-D? Any feedback would be appreciated.Thanks
Sage,Remeron is an anti-depressant that also has 5-HT3 antagonist properties which make it similar in that respect to cilansetron and Lotronex. Take a look at the thread I started on it. Kath M. and Nath are longtime members of this board and gave me lots of useful info on it. With regard to my last post, I want to make clear just how hard Solvay's stock got hit today. It lost about 7% of its total worth in the last half hour of trading. The post about the delay on that Solvay board appeared two hours later. The connection to me seems unavoidable. I realize that I have made predictions about this drug based on what I thought was reliable information that never came true, and I would never in my life be so glad to be wrong about something as I would about this. It could be just that the FDA is taking more time to review the drug, because it caught so much flak for speedy reviews in the past. But the truth is I have no idea what exactly is going on (although the fact that the FDA at least has serious concerns about the drug's safety is clearly what is behind this.) And the scandals at that agency which seemed to be abating slightly just a little while ago are now back with a vengeance since Pfizer announced today that it halted a Celebrex trial because the drug appeared just as dangerous as Vioxx. I am depressed.
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You have to be careful with how the media plays out stories. With Vioxx being withdrawn, they are taking that angle with the Celebrex news. Pfizer where trailing its effects as an anti-cancer medication and where trialing doses from 400mg to 800mg per day. The normal dose for arthitis sufferers is 200mg. The other study being carried out by Pfizer showed no increased risk. One study does not really give a clear indication one way or the other.As for Solvay's stock price it could be from the fall out from this latest batch of bad news. If there is a particular reason why their stock has fallen, there shoudl be some news on it, otherwise how do the stockholders know their is a problem?
Just checked out the Solvay site.I would guess the market was not happy with the dividend announced on the 16th of EUR 0.70, unchanged from 2003.
Thanks Nath,Maybe I overreacted. God knows I have been wrong about this drug before, although I have always had the best intentions when posting. Again, I would infinitely prefer looking foolish for having posted something that proved false than have this be true.
Okay, I may officially be a fool now. According to Reuters that dramatic stock drop was probably due to something called a mistrade by an institutional investor. As for that employee board, I wouldn't take what they say to heart. They obviously hate the company and bad-mouth it to no end. I think I seriously confused correlation between the stock and that rumor with causation between the two. Terribly sorry.
I think I really owe everyone here an apology for posting something so alarming and essentially unfounded. I said before that I would stop writing wild speculation about this drug, but I think fear and despair got the upper hand over my good judgment yesterday. From now on I will seriously keep the flights of my imagination to myself. Once again, sorry.
I'll get to the significance of the picture above in a second, but first I'd like to share with you my thoughts about IBS!Having IBS for 12 years now, I've pretty much accepted the fact that I may never be totally IBS free my entire life. If there is one thing I've learned, it's not to put all your eggs in one basket. You need to be realistic about this condition, and unfortunately that means that IBS may be a "life long condition". The difficult part is making the best out of the hand you've been dealt. In my case that's easier said then done. I was very excited about the release of lotronex, and thought for sure that it would cure me, but that was not the case. Ever since then it's been cilansetron, going on about 2 years now of anticipation. If nothing else these drugs have given me hope and have kept me going. Now about the picture. That picture was taken on top of the Sydney Harbor Bridge in Australia of course. What is the significance of the photo you ask? Well, I was 22 and had been living with IBS for 6 years and had reached a point in my life where I had built up enough confidence to subject myself to a scary climb with no bathroom available for 2 hours and meanwhile being tethered to a bridge. A few close calls since then have shattered my confidence and I've been slowly trying to work my way back up to being able to do something like that again. I guess my point is that there's no need to apologize for misinterpreting Solvay's stock information, we all want Cilansetron to work just as much as you, and we are all excited to here any news about it, good or bad. It's what gives us hope and keeps us motivated.
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No apology needed. Im anxious about the release on Cilansetron too. Lotronex works real well for me but is not available here, where Cilansetron is scheduled to be. I think if it was scraped I would be in denial. Your concern shows how much its release means to you as well. I just hope we are not bitting our nails for too much longer.
Thanks guys,Stay Strong, thanks for sharing your experience. On the subject of hope, please allow me to indulge in a little bit more. I know that scientists at GSK are hard at work using cutting edge genetic research to identify patients likely to benefit or suffer adverse effects from Lotronex. I also understand that Solvay is also now on board with similar research on cilansetron. Eric seems to be the resident expert on this sort of thing and provided me with lots of information about it in the News section. The benefits to both of these drugs in terms of their availability could be huge if this research succeeds. (Indeed, GSK would probably even consider resubmitting Lotronex in other countries if it really pays off.) Unfortunately, this sort of research is still in its infancy and these noble efforts could fail. But since it is hope which sustains us, I will continue to cling to it.
I hadn't followed this postnig, but I have not heard of any difficulties with Cilansetron at the FDA. The FDA must report back in 6 months after receiving the submission. They can ask for further data, but this has not occurred as of yet. Cilansetron had very good phase 3 data to support the submission.Jeff
Thanks Jeff,Again, I'm sorry to have kicked up such a fuss over nothing. But since that 6 month limit is rapidly approaching, do you think the FDA could reach a decision without an advisory committee meeting? I'm not very knowledgeable about how the FDA works but I thought that was standard procedure.
No word yet on whether an advisory meeting will be necessary. From past experience, I think a public discussion is likely going to happen. These class of drugs seem to carry a certain amount of controversy.Jeff
Hopefully this drug will pass, it's some people's only hope right now to deal with D! I hope it comes out soon
Solvay Pharmaceuticals, Inc. Announces 90-Day Extension of FDA Review of the New Drug Application for Cilansetron for the Treatment of Irritable Bowel Syndrome with Diarrhea Predominance (IBS-D)- Joint FDA Advisory Committee Meeting Expected - MARIETTA, Ga., Dec. 20 /PRNewswire/ -- Solvay Pharmaceuticals, Inc.announced today that the U.S. Food and Drug Administration (FDA) has extendedits review of the cilansetron new drug application (NDA). The reviewcompletion date, previously set for January 1, 2005, is now April 1, 2005.Cilansetron is expected to be discussed at a joint Gastrointestinal and DrugSafety and Risk Management Advisory Committee. Solvay Pharmaceuticals isseeking approval to market cilansetron, an investigational 5-HT3 receptorantagonist being studied for the treatment of IBS-D in men and women, andexpects to launch the product in the U.S. shortly following approval in 2005. "We continue to work closely with the FDA as they complete the reviewprocess for cilansetron," said Dr. Harold Shlevin, Solvay Pharmaceuticals,Inc. President and CEO. Solvay Pharmaceuticals' NDA submission includes a comprehensiveCilansetron Appropriate Use Program that was created through a collaborationof physicians, pharmacists, patients, and risk minimization experts andincludes an array of interrelated educational tools and specific promotionalstrategies, designed to facilitate access to cilansetron for the appropriatepatient. Solvay Pharmaceuticals, Inc. ( ofMarietta, Georgia (USA), is a research-driven pharmaceutical company thatseeks to fulfill unmet medical needs in the therapeutic areas of cardiology,gastroenterology, mental health, women's health and a select group ofspecialized markets including men's health. It is a part of the global SolvayPharmaceuticals organization whose core activities consist of discovering,developing and manufacturing medicines for human use. Solvay Pharmaceuticals,Inc. is a subsidiary corporation of the worldwide Solvay Group of chemical andpharmaceutical companies headquartered in Brussels, Belgium.SOURCE Solvay Pharmaceuticals, Inc.
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Thanks Jeff,I suppose things could be much worse. Hopefully this extra three months of review will enhance the legitimacy of the FDA's decision, which could be particularly crucial given the current situation at that agency and the controversy surrounding this class of drugs. Let's just hope they decide the way everyone here is praying they do.
HiMr/Ms Johnson I appreciate your concerns Is Cilanestron supposed to be safer than Lotrone ?I was on Lotronex but had to go off it because Ihave DVT ( Blood Clots) in my legs My Gastro and Internist thought it would be ok for me to try Lontonex .Didnt notice much differance in "D" prevention, and had to go off it when I developed a few new clots I hope Cilanestron will be safer I am in the worse 5% of IBS "D" and am holding hope that I might get a small part of my life back. A lready have Fibro Permanent Dizzies Sjrojens This is hard to bear but like you am coping Waht else can we do Thanks Rose, A IBS Swede
Hey Rose,Cilansetron unfortunately had similar rates of ischemic colitis in trials as Lotronex. The drug's sponsor, Solvay, has claimed that these effects were "much milder" with their drug. I don't know if this is true or is simply drug company PR. I guess we will have to wait till the advisory committee meeting in March for the truth to come out.
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