The US Food and Drug Administration (FDA) has approved a fixed-dose combination of doxylamine succinate and pyridoxine HCI (Bonjesta, Duchesnay) for the treatment of pregnancy-related nausea and vomiting in women who do not respond to conservative management.
Each extended-release tablet contains 20 mg of doxylamine succinate, an antihistamine, and 20 mg of pyridoxine HCl, a vitamin B6 analog.
"The combination of doxylamine succinate and pyridoxine HCl has been the subject of many epidemiological studies designed to detect possible teratogenicity. No increased risk for congenital malformations has been reported based on these studies," according to a news release announcing the approval.
Bonjesta has not been studied in women with hyperemesis gravidarum.
Bonjesta will be available in extended-release tablets in 100-count bottles. The tablet should be taken on an empty stomach because food may delay the onset of action.
Duchesnay also markets Diclegis, which contains doxylamine succinate 10 mg and pyridoxine HCl 10 mg, for a similar indication.
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Cite this: FDA Clears New Drug for Pregnancy-Related Nausea/Vomiting - Medscape - Nov 15, 2016.