once indiplon gets to market they will be able to pummel lunesta with this data - and considering that SEPR did not do impairment test til 9.5-10.25 hours post dosing to hide impairment will make it even easier
Driving Study Preliminary Results
Neurocrine recently completed a randomized, double-blind, active- and placebo-controlled, four-way crossover, out-patient clinical trial conducted in 30 healthy volunteers to measure the impairment on next day driving performance after nighttime administration of indiplon 10mg, and 15mg, zopiclone 7.5mg or placebo. Following nighttime administration of indiplon there was no statistical difference for either indiplon dose vs. placebo on measurements of driving performance in a simulator, the primary endpoint in the study. These preliminary results also showed that zopiclone exhibited statistically significant impairment on driving performance. Safety results with indiplon were consistent with those previously reported in studies with indiplon 10mg and 15mg.
this is from the Q1 SEPR CC
Q � Greg Gilbert, Merrill Lynch
One for Dr. Roach: at what hour were the patients measured in the driving study, and how do you think that will compare to other studies that come out for competitive agents over time?
A � James Roach
I think the hour that it was measured is very consistent with the hour that it�s measured in many driving studies and we look forward to presenting these results, as I said, in an upcoming scientific meeting. It was between 9.5 and 10.25 hours.
Sorry wrong message # should have been 25837: I'll repost it for you
Published somnolence data for
by: otc_buzzard 06/24/06 04:19 pm
Msg: 25837 of 25949
Lunesta and for Indiplon
Incidence of somnolence reported in clinical studies for Lunesta 2m: 10%, Lunesta 3mg: 8%
Commonly reported adverse events at the 10-mg dose included headache (11.8%), back pain (7.9%), and somnolence (7.9%).
As you can see, instead of just throwing numbers out there I have added links to supporting evidence, unlike pinhead.
As you can see, there is no real difference between lunesta and indiplon in regards to somnolence.
"SEPR causes impairment when measured at 8 hours post dose"
Another unsubstantiated claim. Sorry if I don't take your word for it. Link please?
Otc_buzzard has already refuted you in message 25637. Your answer was totally unsatisfactory.
If you don't address the weak points in your arguments with evidence and continue to assert unsubstantiated claims I have to question your motives.
this is the second time you have posted an IR study and implied that it goes for the MR preparation too. If you want to show IR data, then compare it to sonata not lunesta. IR is not the problem (its just not much of a market).
You use to post good science. Now you are trying to mislead.
pinvestment, could you provide some color on when nbix submitted nda's for lower doses of IR and MR than were initially tested.
My recollection, now, is that earlier tests were done at substantially higher doses - possibly 10,20 mg for IR and 20,25,30,35 mg for MR.
Then the NDA's were submitted at lower doses -what is the possible explanation?
I haven't heard much discussion on labeling issues. Could the label be a PFE reason for cutting and running? The drug may get full approval, but they may not get the label they want, ie. long-term use.
Is it possible lunesta is closer to approval on the better label?
i have the chronological order of the phase III on my other computer - i can repost them - they seemed to be working towards lower doses on all fronts - but not as clear as you might think
I thought the effort to use lower doses was driven by the desire to crush ambien and lunesta on the side effect issue - ambien is too dirty, and lunesta is less dirty but has a six hour half-life - thus by the time the person would take the dose the next night there still would be drug in the bloodsteam - hypoethetically it should build up over time
lunesta given at 1200AM - lets give lunesta level in blood a number (100) - by 6 AM lunesta in blood is 50 by 12 noon it is 25 by 6PM it is 12.5 by midnight when new dose is given it is 6.25 - thus on night #2 new starting dose is 106.25 / 6AM 53.12 / 12 noon 26.6 / 6 PM 13.3 / midnight 6.65 - and the drug level continues to rise to a higher steady state
thus SEPR needs to do impairment studies on short term studies - and because of half life that is why SEPR does impairment test at 9.5 -10.25 hours post dosing ( because it fails at 8 hours post dose ) - you have to love drug companies , don't make a better drug , just develop your testing to hide the fault and higher more sales people to bury your crappy results in a higher noise level
I would be ashamed to hold SEPR
ofweon, now look at the efficacy data for lunest and indiplon 5 and 10 mg, then ask the question of why anyone would want to approve indiplon or even use it in comparrison to lunesta. Tia.
Indiplon 5 and 10 mg is just another "me too" drug in this class, hence the reason that PFE ran away after spending $400mm
Again pinvestment is not doing his research. I do not know where you got this Lunesta data from, but read the FDA approved precribing information for Lunesta. Only 1 out of 4 studies looked at impairment of Lunesta 9.5-10.25 hours post dose.
The Neurocrine driving study only had 30 patients. Not a laarge enough clinical trial to mean anything. Also Neurocrine study used zopiclone which is not Lunesta. Using a higher does of the s-isomer of Lunesta...aprox 3.75mg than is currently approved in the US - currently only approved up to 3mg.
You are trying to spin this Indiplon data to make it look better than it is. Obviously the FDA agrees the data is not good enough at this point....as well a Pfizer.
You claim to know your science, but clearly to not have an undestanding of how the FDA evaluates a drug.