RedHill Biopharma Initiates Co-Promotion of HIV/AIDS Anti-Diarrheal Drug Mytesi®

RedHill Biopharma (NASDAQ:RDHL) has announced it has initiated promotion of Mytesi, a anti-secretory prescription drug product of Napo Pharmaceuticals approved by the US FDA for the symptomatic relief of non-infectious diarrhea in adults with HIV/AIDS on anti-retroviral therapy.

As quoted in the press release:

RedHill’s co-promotion efforts will target gastroenterologists and select primary care physicians in the U.S., complementing the efforts of Napo’s direct sales force, which has been fully deployed since the second quarter of 2018.

Mytesi^® is the only drug that has been specifically studied in and FDA-approved for use in managing non-infectious diarrhea in people living with HIV/AIDS. The ADVENT study was a long-term Phase III, multicenter, randomized, placebo-controlled trial that enrolled 274 patients treated with either Mytesi^® 125 mg bid or placebo. The results from ADVENT, which have previously been reported by Napo and Jaguar, show that by week 20 89% (n=162) of participating patients experienced a decrease in watery stools, with 83% having at least a 50% decrease; 72% at least a 75% decrease, and 56% a 100% decrease.

RedHill’s U.S. commercial operations, headquartered in Raleigh, NC, include a gastrointestinal-focused sales force of approximately 40 sales representatives commercializing and promoting four GI-specialty products, Donnatal^® (Phenobarbital, Hyoscyamine Sulfate, Atropine Sulfate, Scopolamine Hydrobromide)², EnteraGam^® (serum-derived bovine immunoglobulin/protein isolate, SBI)³, Esomeprazole Strontium DR Capsules 49.3 mg and Mytesi^® (crofelemer 125 mg delayed-release tablets)⁴ in select U.S. territories. RedHill’s U.S. commercial operations are setting the stage for the potential U.S. launch of RedHill’s late clinical-stage products, including TALICIA^® (RHB-105)⁵ for H. pyloriinfection, with confirmatory Phase III study top-line results expected in the fourth quarter of 2018.

Click here to read the full press release.