The Canadian pharmaceutical company Duchesnay Inc. sets for international expansion following the US approval of its morning sickness medication Diclegis® by the FDA
BLAINVILLE, QC, April 9, 2013 /CNW Telbec/ - Following the US approval
of its morning sickness medication Diclegis by the US Food and Drug Administration (FDA), the Canadian pharmaceutical company Duchesnay Inc. is proud to announce that this approval sets the obstetric medicine
specialty company for international expansion.
Diclegis has been available in Canada under the trade name Diclectin®
for more than 30 years as the only prescription drug specifically
indicated and approved for the management of nausea and vomiting of
pregnancy (NVP), also known as morning sickness. Diclegis® will be
commercialized in the US by Duchesnay USA based in Rosemont, Pennsylvania. The FDA granted Pregnancy Category "A"
status to Diclegis, which means the results of controlled studies have
not shown an increased risk to an unborn baby during pregnancy.
"The US approval of the patented drug Diclegis, (Diclectin in Canada)
by the FDA represents an important milestone for Duchesnay as we plan
for strategic expansion through international partnerships. We will
leverage our long-standing and prominent expertise as an obstetric
medicine company to reach key markets in Europe, Asia-Pacific and Latin
America, where millions of pregnant women could beneficiate from our
health products," stated Éric Gervais, Executive Vice-president of
Diclectin delayed-release combination of doxylamine succinate and
pyridoxine hydrochloride is the only prescription antinauseant and
antiemetic drug labeled and approved in Canada for use in pregnancy.
Its long and outstanding track record of safety and efficacy has made
Diclectin the drug of choice in Canada in the clinical guidelines of
the Motherisk Program at the Hospital for Sick Children in Toronto and the Society of Obstetricians and Gynaecologists of Canada (SOGC). Diclectin has been used by over two million pregnant women in Canada.
ABOUT NAUSEA AND VOMITING OF PREGNANCY (NVP)
Nausea and vomiting of pregnancy (NVP), commonly called morning
sickness, affects between 70 to 85 percent 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. If left untreated, symptoms can sometimes
progress to a potentially more serious condition called hyperemesis
gravidarum (HG), which may require hospitalization. NVP can have a
dramatic impact on the emotional and physical well-being of the
expectant woman and her family. NVP has also been shown to impose an
economic burden on healthcare system and productivity lost.
Duchesnay Inc. is a privately held Canadian pharmaceutical company
dedicated to improve the health and quality of life of pregnant women
and to the advancement of maternal-fetal medicine and scientific
research to reduce the risk of birth defects. Duchesnay develops safe
and effective pharmacological solutions for use during pregnancy and
breastfeeding. For more information, visit www.duchesnay.com.