Table of Contents
ROSEMONT, Pa. — Duchesnay USA has shipped Diclegis, a medication for morning sickness, to pharmacies nationwide.
The company said Tuesday that Diclegis (doxylamine succinate 10 mg and pyridoxine hydrochloride 10 mg) offers pregnant women suffering from nausea and vomiting of pregnancy (NVP) a safe, effective option for reducing symptoms when conservative management, such as diet, have failed.
The Food and Drug Administration approved Diclegis early last month. According to Duchesnay, the medication is the first FDA-approved treatment for morning sickness in over 30 years.
"We believe Diclegis will become an important treatment for health care professionals caring for pregnant women with nausea and vomiting of pregnancy," stated Gilbert Godin, chief executive officer of Duchesnay USA, which describes itself as "the first pharmaceutical company dedicated to the health of pregnant women."
Diclegis has received a "Pregnancy Category A" status from the FDA, which signifies that the results of controlled studies haven’t shown an increased risk to an unborn baby, Duchesnay noted.
"The product’s safety profile and its proven clinical effectiveness make it a convenient and innovative treatment for women who are seeking effective NVP-symptom relief," according to Godin.
Pregnant women prescribed Diclegis take two tablets at bedtime daily and, if symptoms aren’t adequately controlled, the dose can be increased over a period of three days to a maximum recommended dose of four tablets daily: one in the morning, one mid-afternoon and two at bedtime, Duchesnay said. Diclegis is intended to be taken as a daily prescription and not on an as-needed basis to help control symptoms throughout the day, the company added.
NVP affects 70% to 85% of pregnant women, with symptoms ranging from nausea to severe vomiting, and some women may experience symptoms throughout their pregnancy, Duchesnay reported.
