RE:RE:RE:RE:Keep this in mind LONGs ... Thanks for your response Magic. I was referring more to your thoughts on why Oten would be used off label for chronic. I don't necessarily agree with this point of view. Oten is being developed as a prescription drug. Use for chronic would require a doctor's collaboration...a risky venture given ATE's liver history.
The AME LTEs were more concerning than they might first appear. The standard hepatotoxicity warning that is provided with most NSAIDs is that past trials have revealed elevated LTEs greater than 3 X ULN in 1% of the participants. AME 100mg Oten revealed 25X this number (5/20) with LTEs greater than 5 X ULN, for a study with low dose and short duration. The LTEs appear to be time-dependent.
Drug manufacturers cannot promote off-label use without FDA concurrence. Further, both the EMA and the FDA can require a manufacturer to undergo appropriate testing if it believes that a drug will be used for a different purpose.
Here is what the EMA has to say about this (for pain drugs): "For drugs intended for long-term treatment, safety data are required in a sufficient number of the target population from clinical studies of at least 12 months duration. Long term data may also be required for drugs intended for repeated use in acute pain or for which off label long term use is plausible." A key word is "plausible".
Not a far fetched hypothetical. Wallace is, or should be aware of this given his past affiliation with NicOx and its Osteoporosis drug naproxcinod. Lots of stuff about this posted on the web, but you have to dig. The bottom line is that NicOx was required to undergo long term cardiovascular studies after its NDA submission due to prior comments made in the media about its CV benefits. A bummer...
Perhaps this is part of the reason why chronic has been ghosted from the deck and management rarely talks about it anymore. I hope that management remains focused on acute until it crosses the finish line. Post NDA acceptance might be a more approriate time to pusue chronic in earnest. Just my opinion.