The US Food and Drug Administration (FDA) has granted approval to Duchesnay USA's Diclegis (doxylamine succinate 10mg, pyridoxine hydrochloride 10mg) delayed-release tablets for the treatment of nausea and vomiting of pregnancy (NVP) in women who do not respond to conservative management. It is the only FDA-approved treatment for NVP, more commonly known as morning sickness, in more than 30 years.

The US FDA granted Diclegis Pregnancy Category A status which means the results of controlled studies have not shown an increased risk to an unborn baby during pregnancy. The two active ingredients in Diclegis that reduce nausea and vomiting in pregnancy – doxylamine succinate and pyridoxine hydrochloride, or vitamin B6, – have been recommended as a first-line pharmacotherapy by the American Congress of Obstetricians and Gynecologists (ACOG) guidelines for the last nine years.

“The FDA approval of Diclegis provides an important new treatment to the millions of women suffering from nausea and vomiting of pregnancy, and fills a 30 year void in the treatment of NVP,” said Gilbert Godin, chief executive officer, Duchesnay USA. “Duchesnay USA is honoured to bring the only FDA-approved treatment to help control symptoms of morning sickness to market. Duchesnay has been dedicated to the health of pregnant women and their unborn children for years and is taking every step to make Diclegis available for women suffering from NVP.”

NVP is a medical condition that affects 70 to 85 per cent of pregnant women with symptoms ranging from nausea to severe vomiting and retching that can last throughout the day. Some pregnant women may experience symptoms throughout their pregnancy.

Dr Shannon Clark, associate professor, Division of Maternal and Fetal Medicine, University of Texas Medical Branch – Galveston said, “Millions of pregnant women suffering every year from nausea and vomiting of pregnancy now have a safe and effective FDA-approved treatment. Until now, women have been without an FDA-approved prescription options to help treat NVP symptoms, also known as morning sickness.” Dr Clark further added, “Diclegis provides a safe and effective option for pregnant women. Its active ingredients are the most studied for this purpose.”

Diclegis is expected to be widely available in the US by the end of May 2013. Diclegis has proven to be a safe and effective treatment option for nausea and vomiting of Pregnancy (NVP). 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, seven 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.

Duchesnay USA is a unique healthcare company devoted to safeguarding the health and wellbeing of expectant mothers and their unborn babies.