The drug usage under review (and which the panel considered) was as a pain reliever for AIDS patients. I am assuming the pain associated with AIDS is chronic in nature, versus acute (in other words long term versus short term). Unfortunately the testing showed it more effective at 30 minutes than existing pain relievers but not more effective at 60 minutes (therefore more effective against acute pain versus chronic pain). While not fully understanding the pain reliever market, I would anticipate the strong possibility of a new NDA centering this around acute pain and using at least some of the trial data generated for the current FDA application thus hopefully reducing some trial time.
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