jogom wrote:As i see, AVP-923 failed to be approved by FDA, because on the tials there were death people. Really very sad for us, because it was very promising.
Hi, I may not have seen the same report that you've seen, but I do not think that this is exactly the case for AVP-923.
A few years ago Avanir had higher rate of death in the drug treated group than in the placebo group in a study for treating ALS / Lou Gehrig's disease. I do not believe that there was any similar problem in the diabetic neuropathy studies.
I've learned, unfortunately, that the drug is on hold for the indication of diabetic neuropathy for several reasons:
1. Avanir conducted their diabetic neuropathy studies using 30 mg quinidine when they now prefer to use 10 mg (for perceived safety reasons I believe).
2. Avanir wants to focus on neuropathy for multiple sclerosis, a niche market with no competition and requiring a smaller salesforce. This is in phase 2 and uses the 10 mg quinidine dose.
Bottom line is that there will be much delay for AVP – 923, but I do no believe it has failed. Please let me know if you seen any recent news report that says otherwise.