earliest MR15Mg on the market is mid FY08, just remember 90 days for DEA, IMO, more like early FY09 as its going to take time to get a 3 to 6 month most likely 500+ patient trial, (will also need to do an elderly trial) set-up and going and even with a class 2 review cycle of 6 months its a long slugg for 15Mg Indiplon to market. Generic Ambien will be on the market by March,07 the latest. Lunesta has a very very good label, and its the only sleep drug with a 6 month profile as part of its label. (indiplon 15Mg would of been 3 months) will have a solid patient population by 08/09 timeframe which will be very hard for indiplon to penatrate and I read the label/package insert, can you point out the specific lines from the (package insert) where the FDA talks about Lunesta causing Cancer I must of missed it. I think Fluff is missing the point, big-time.
Stebbing J, Waters L, Davies L, Mandalia S, Nelson M, Gazzard B, Bower M. Related Articles, Links Incidence of cancer in individuals receiving chronic zopiclone or eszopiclone requires prospective study. J Clin Oncol. 2005 Nov 1;23(31):8134-6.
Again is it a safety issue in the label/packet insert? "NO" it is not, end of story. I have not seen one sellside analyst pro or con on Sepracor place any credence on the cancer BS. I was at a MEDACorp investor panel discussion on Lunesta last year and it was a non-issue,and if the FDA doesn't have an issue, its a non-issue. The FDA cares more about the Hulluncinations that the 20 & 30Mg versions of Indiplon have caused. safety is job#1 at the FDA these days.
Beachbarboob, if you take a sleeping pill I think Lunesta is the one for you. Aside from the metallic taste it gives you, your waking up with nightmares, and the fact that ambien will put you to sleep faster, I think for you Lunesta is the drug of choice since you appear sold on it. Oh who cares in a few years if you might get cancer, I wouldn't worry if it doesnt' say anything on the label. I am sure it mentions on the label bad taste and nightmares are part of the getting a good night's sleep. LOLLLLL
No, I don't think fluff is missing the point but you should ask him what he recommends as a good sunscreen lotion to apply on your a__ for the bad burn you got shorting Elan. If you don't believe him in regard to Elan or NBIX, maybe you will give him the benefit of the doubt on suntan lotions - remember he is a doctor and you should always follow a doctor's advice or maybe eat an apple a day. LOLLLLL
lunesta label has mutagenicity studies on page 10/11 - for each study that showed mutagenicity they just did some other version of the test to try to make it go away - as you can see mutagenicity was postive for one test so they just used another test to make it go away
when they ran into neoplasia problems with the longer term use - they analyzed shorter term data to dilute it out
also SEPR impairment test was done 9.5-12.5 hours after dosing - another nice way to hide impairment that would have been seen at 8 hours - thus when NBIX tested zopiclone versus indiplon at 8 hours - there was not impairment for indiplon but statistically significant impairment for lunesta