Elite Pharmaceuticals Inc (ELTP)

[WeeZuhl]

Pro-drugs are cute but not abuse deterrent





Example: KemPharm's Apadaz (prodrug of Norco). Received FDA approval last week after initially getting CRL due to lack of snorting abuse-resistance. As far as I can tell, the approval was given without any modification, but there is no ADF label. Unless they can figure out a market niche for a very expensive version of Norco without an ADF label, all they have is a new Oxaydo (no commercial viability).


Like most pro-drugs, Apadaz has some inherent overdose protection. Kempharm's studies show that there is a decrease in plasma concentration when *EIGHT* (8!!!) tablets are taken. In other words, not much help. Prodrugs are very finicky. Don't believe anything you hear until the data is available to prove it.