The New Drug Application submission with the FDA 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 significantly larger improvement in symptoms of NVP compared with placebo, based on the PUQE score. This study concluded that Diclegis delayed release formulation of doxylamine succinate and pyridoxine hydrochloride is effective and well tolerated in treating NVP. iDiclegis Dosage and Administration
FDA Approves Duchesnay USA's Diclegis® For Treatment Of Nausea And Vomiting Of Pregnancy (NVP)
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