New Findings on Morning Sickness Treatment Presented at Society for Maternal-Fetal Medicine Annual Pregnancy Meeting

Early use of Diclectin^® reduces the severity of nausea and vomiting of pregnancy (NVP) symptoms in pregnant women who had severe NVP in a previous pregnancy

BLAINVILLE, QC (CANADA), Feb. 14, 2013 /PRNewswire/ - Duchesnay Inc. announced results from a new study concluding that pre-emptive use of Diclectin^® (a delayed-release combination of 10 mg doxylamine and 10 mg pyridoxine) is effective in reducing symptoms of severe NVP in patients at high risk for recurrence of severe NVP. The study was conducted by Gideon Koren, M.D., and Caroline Maltepe, B.A., of The Motherisk Program, Division of Clinical Pharmacology and Toxicology, Hospital for Sick Children in Toronto, Ontario. Data were presented in an oral abstract in San Francisco, California on February 14, 2013 during the Society for Maternal-Fetal Medicine's Annual meeting 'The Pregnancy Meeting', and will be published in the American Journal of Obstetrics and Gynecology¹.

The randomized, controlled study recruited pregnant women who had experienced severe NVP or hyperemesis gravidarum (HG) - an extreme form of morning sickness - in a previous pregnancy. These women were instructed either to start using Diclectin^® before NVP symptoms appeared (the pre-emptive group), or to start Diclectin^® at the first sign of NVP symptoms (the control group). The severity of NVP symptoms was compared between the two groups.

Results demonstrate that women who started using Diclectin^® before NVP symptoms began had significantly reduced symptoms of severe NVP compared to women who only started Diclectin^® when NVP symptoms appeared. In the pre-emptive group, there were 70% fewer cases of moderate-to-severe NVP compared to the control group during the 3 first weeks of NVP (p=0.05). Pre-emptive use of Diclectin^® was also found to decrease the recurrence of HG in women with a previous history of HG (p=0.047).

"Women with NVP commonly report feeling unsupported by the medical community, and many physicians and pharmacists are hesitant to prescribe anti-emetics to pregnant women," said lead researcher Dr. Gideon Koren. "These new, important data continue to prove that NVP is a serious medical condition, and drive awareness of safe and effective treatment options to alleviate NVP symptoms and possibly prevent extreme cases of hyperemesis gravidarum."

The delayed release combination of 10 mg doxylamine and 10 mg pyridoxine (Diclectin^®, Duchesnay, Inc.) is labeled in Canada specifically for NVP, and has been shown to be safe and effective in more than 200,000 pregnant women.^2,3

About the Motherisk Program
The Motherisk Program is a clinical, research and teaching program dedicated to drug, chemical, and disease risk counselling in pregnancy. Motherisk provides evidence-based information and guidance about the safety or risk to the developing fetus or infant, of maternal exposure to drugs, chemicals, diseases, radiation and environmental agents.  The program maintains several Helplines, one of which is the toll-free NVP Helpline which was created to improve the management of NVP.

About NVP and HG
Nausea and vomiting of pregnancy, or morning sickness, affects up to 85% of pregnant women, with symptoms that range from nausea to severe vomiting and retching.⁴ More than half of pregnant women report daily episodes of vomiting.³ For most pregnant women, symptoms generally decrease between 12-16 weeks gestation.⁵ However, some women can experience symptoms throughout their pregnancy,^3,4 and 40% of women experience symptoms severe enough to interfere with their lifestyle.³ Although NVP is not usually a life-threatening medical condition, if left untreated, it may progress to HG.¹ HG occurs in up to 3% of pregnant women and may require hospitalization to care for nutritional deficiency, weight loss, and fluid, electrolyte and acid-based imbalances.^1,6 The American Congress of Obstetricians and Gynecologists (ACOG) advocates that early treatment of NVP may prevent the escalation of symptoms that lead to HG.⁷

About Duchesnay Inc.
Duchesnay Inc. is a unique healthcare company exclusively devoted to safeguarding the health and well-being of expectant mothers and their unborn babies. Founded in 1970 in Canada, the family-owned company realigned its business in 1992 to focus specifically on pregnant women after a family member experienced a very difficult pregnancy. Duchesnay's mission became to improve the health and quality of life of pregnant women by working at advancing maternal-fetal medicine to reduce the risk of birth defects and by developing safe and effective pharmacological solutions for use during pregnancy and breastfeeding. For more information, visit www.duchesnay.com.

______________________________
¹ Koren G, Maltepe C.  Preemptive Diclectin therapy for the management of nausea and vomiting of pregnancy and hyperemesis gravidarum.  AJOG. 2013 208:1 (Suppl): 20.
² Clark SM, Costantine MM, Hankins GD. Review of NVP and HG and early pharmacotherapeutic intervention. Obstet Gynecol Int. 2012 25: 2676. Epub 2011 Nov 24.
³ Ebrahimi N, Maltepe C, Einarson A. Optimal management of nausea and vomiting of pregnancy. Int J Women's Health. 2010 2: 241-8.
⁴ "Nausea and Vomiting of Pregnancy," Association of Professors of Gynecology and Obstetrics. 2011.
⁵ Lacroix R, Eason E, Melzack R. Nausea and vomiting during pregnancy: a prospective study of its frequency, intensity, and patterns of change. Am J Obstet Gynecol. 2000 182:931-937.
⁶ Verberg, MFG, DJ Gillott, N Al-Fardan and JG Grudzinskas. Hyperemesis gravidarum, a literature review. Human Reproduction Update. 2005 11(5): 527-549.
⁷ "Nausea and Vomiting of Pregnancy," ACOG Practice Bulletin # 52, 2004.

SOURCE Duchesnay inc.