Duchesnay USA announced that Bonjesta (doxylamine succinate, pyridoxine HCl) extended-release tablets are now available for the treatment of nausea and vomiting of pregnancy (NVP) in women who do not respond to conservative management.
Bonjesta combines doxylamine succinate, an antihistamine, and pyridoxine HCl, a vitamin B6 analog. It was initially approved by the Food and Drug Administration (FDA) in November 2016 based on the safety and efficacy data of Diclegis (doxylamine succinate, pyridoxine HCl) delayed-release tablets from a double-blind, randomized, multi-center, placebo-controlled study (N=256). Treatment with doxylamine succinate and pyridoxine HCl 10mg/10mg led to a 0.7 mean decrease (95% CI: 0.2–1.2; P=0.006) from baseline in Pregnancy Unique-Quantification of Emesis (PUQE) score at Day 15 vs placebo.
Also, the approval was supported by data from a single-dose bioequivalence study, a multi-dose bioequivalence study, and a food-effect study.
Bonjesta is available as 20mg/20mg strength tablets in 60- and 100-count bottles.
For more information call (855) 722-7734 or visit Bonjesta.com.