Duchesnay USA announced that the FDA has approved Diclegis (doxylamine succinate and pyridoxine HCl) delayed-release tablets for the treatment of nausea and vomiting of pregnancy (NVP) in women who do not respond to conservative management. Diclegis, an antihistamine and vitamin B6 analog combination, is the only FDA-approved treatment for “morning sickness” in over 30 years. The product was granted Pregnancy Category A status indicating that results of controlled studies have not shown an increased risk to an unborn baby during pregnancy.
The approval was based on a 15-day double-blind, randomized, multi-center, placebo-controlled trial studying pregnant women >18 years old, 7–14 weeks gestation with NVP. Treatment with Diclegis resulted in significantly larger improvement symptoms of NVP compared to placebo, based on the PUQE score. Diclegis has not been studied in women with hyperemesis gravidarum.
Diclegis will be available as a combination delayed-release tablet containing 10mg of doxylamine succinate and 10mg of pyridoxine HCl. Diclegis is expected to available by the end of May 2013.
For more information call (855) 722-7734 or visit www.diclegis.com.