Dr. Hylton V. Joffe, director of the Division of Reproductive and Urologic Products in the FDA's Center for Drug Evaluation and Research, said Diclegis, or doxylamine succinate and pyridoxine hydrochloride, is a delayed-release tablet intended for women who have not adequately responded to conservative management of nausea and vomiting during pregnancy, such as lifestyle modifications.
These modifications include eating several small meals instead of three large meals, eating bland foods that are low in fat and easy to digest, and avoiding smells that can trigger nausea, Joffe said.
Study participants in the clinical trial were at least age 18 and had been pregnant for at least seven weeks and up to 14 weeks. Women were randomly assigned to receive two weeks of treatment with Diclegis or a placebo.
The study results showed pregnant women taking Diclegis experienced greater improvement in nausea and vomiting than those taking the placebo.
Additionally, observational -- epidemiological -- studies showed the combination of active ingredients in Diclegis does not pose an increased risk of harm to the fetus, Joffe said.
"Many women experience nausea and vomiting during pregnancy, and sometimes these symptoms are not adequately managed through recommended changes in diet and lifestyle," Joffe said in a statement. "Diclegis is now the only FDA-approved treatment for nausea and vomiting due to pregnancy, providing a therapeutic option for pregnant women seeking relief from these symptoms."
The is marketed by Duchesnay Inc., in Blainville, Quebec.