InvestorsHub Logo
icon url

joseytheoutlawwales

12/26/18 6:23 PM

#252696 RE: loanranger #252695

A good example is Neurontin. Initial indication was solely as an anti-seizure membrane stabilizer.
If I recall correctly, post-herpetic neuralgia was added at some point.

However, FOR YEARS serious numbers of patients were prescribed neurontin (gabapentin) OFF-LABEL for peripheral neuropathy.

icon url

Areader

12/26/18 6:40 PM

#252697 RE: loanranger #252695

I'm a doc. Off-label use is done all the time for a variety of drugs. The only way the FDA would get involved in off-label use is if the use of the drug for an indication other than that for which it were approved, proved dangerous. Hard to imagine that would be the case, here.

Also, once oncologists, hospitalists and primary care docs (who will still be caring for their cancer patients) see that B not only mitigates, but can prevent this awful side effect, they will certainly start prescribing it for their other cancer patients undergoing similar treatments with the potential for OM. Cancer patients themselves and their families in support groups, or talking/meeting each other in outpatient oncology offices or cancer wards, would start demanding it. Docs will publish studies in various journals studying B and OM in other cancers, totally separate from having to do another FDA trial.

If B gets approved for this one indication, I really would not worry at all about its not being prescribed for others.