NDA Submitted for Crofelemer for HIV-Associated Diarrhea
Salix announced that it has submitted a New Drug Application (NDA) to the FDA for crofelemer for the treatment of HIV-associated diarrhea. Crofelemer has been studied in Phase 3 trials that demonstrated relief of diarrhea for a highly statistically significant proportion of patients for crofelemer compared to placebo.
Crofelemer is a locally-acting, minimally-absorbed product that is believed to possess dual novel mechanisms of action that might be effective in treating both acute infectious diarrhea and chronic diarrhea.
For more information call (919) 862-1000 or visit www.salix.com.