In drug development, making a good drug is only half the battle; the drug also has to have side effects appropriate for the disease it's treating.
It's that last part -- the disease it's treating -- that's crucial. The side effects from Johnson & Johnson's
Given the strong efficacy, most of the only discussion is likely to revolve around whether the side effects swamp out the good the drug is doing. The biggest issue here is that the drug causes urinary retention, essentially the inability to urinate. For the most part, the issue was reversible, and given the symptoms of epilepsy that aren't under control in this patient population, I think it's likely that the panel of outside experts will mostly shrug off the side effects.
That's not to say Potiga will be a blockbuster; the side effects likely will keep Potiga from ever becoming a first-line treatment -- remember that "disease it's treating" part. But considering the lack of other options, Glaxo and Biovail
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