FDA approves return of morning sickness drug

Hannah Blake

pharmaphorum

The US FDA has approved a generic version of a morning sickness treatment for pregnant women that was withdrawn from the market 30 years ago.

The original treatment, called Bendictin, was withdrawn following a series of lawsuits from mothers claiming there were safety concerns. However, the manufacturer at the time – Merrel Dow – confirmed it had withdrawn the drug because it simply could not afford to defend itself in court, not that the drug was ineffective.

The new drug Diclegis (doxylamine succinate and pyridoxine hydrochloride) is made by Duchesnay Inc, a private Canadian company.

Diclegis is a delayed-release tablet intended for women who have not adequately responded to conservative management of nausea and vomiting during pregnancy, such as dietary and lifestyle modifications, such as eating several small meals instead of three large meals.

“Many women experience nausea and vomiting during pregnancy, and sometimes these symptoms are not adequately managed through recommended changes in diet and lifestyle. 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.”

Hylton V. Joffe, M.D., M.M.Sc., director of the Division of Reproductive and Urologic Products in the FDA’s Center for Drug Evaluation and Research.

Diclegis was evaluated in a clinical trial of 261 women of at least 18 years old between 7 and 14 weeks pregnant who were experiencing nausea and vomiting. The study results showed that women taking Diclegis experienced greater improvement in nausea and vomiting than those taking placebo. Additionally, observational (epidemiological) studies have shown that the combination of active ingredients in Diclegis does not pose an increased risk of harm to the fetus.

Duchesnay plans to launch sales of Diclegis in the US in June 2013.