FDA approves Diclegis (Duchesnay USA) for treatment of Nausea in pregnancy
The FDA has approved Diclegis (doxylamine succinate/pyridoxine hydrochloride) delayed-release tablets, from Duchesnay USA, for the treatment of Nausea and vomiting of pregnancy (NVP) in women who do not respond to conservative management. The NDA submission was based on a 15-day double-blind, randomized, multi-center placebo-controlled trial studying pregnant women 18 years of age or older, 7 to 14 weeks gestation, with NVP.
Use of Diclegis resulted in a significant improvement in symptoms of NVP compared with placebo, based on the PUQE score. This study concluded that Diclegis delayed release formulation is effective and well tolerated. Diclegis is expected to be widely available in the US by the end of May 2013.
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