The FDA had granted Napo Pharmaceuticals orphan drug status for its pro-posed drug Fulyzaq™ (crofelemer) to treat non-infectious diarrhea in HIV/AIDS patients undergoing antiretroviral therapy. Facing a short timeframe to prove treatment efficacy and achieve the exclusivity protection of or-phan status, Napo chose to pursue an innovative, adaptive trial design combining the traditionally separate Phase 2 and Phase 3 studies into one continuous trial.

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