A Safe and Effective Drug for Morning Sickness- A Large New American Study Reports
To view the B-Roll Video, please enter the following address in your web browser.
Morning sickness affects up to 80% of pregnant women, and many of them need relief from their symptoms to be able to function at home and at work. The only drug ever approved by the FDA for morning sickness was Bendectin(R), which was similar to the presently tested Diclectin(R). Bendectin(R) was removed from the American market in 1983 due to litigations claiming it caused birth defects. Large studies involving over 200,000 pregnant women and their children refuted the claim of fetal risk, and two FDA committees concurred that Bendectin(R) was safe. Over the ensuing years, American courts rejected all claims of malformations against the drug manufacturer. After its removal from the American market, a
“We are very pleased that this study adds to the extensive information available on the efficacy and maternal safety of Diclectin(R)”, stated Eric Gervais, Executive Vice-President of Duchesnay. “Our product has been available on the Canadian market for over three decades as the only approved safe and effective treatment for nausea and vomiting of pregnancy, commonly referred to as morning sickness. Duchesnay is committed to using this wealth of clinical information to bring Diclectin(R) to
The present study, conducted as part of the FDA submission for Diclectin, was carried out in 3 university centers in the US:
“Having a role in making this treatment for nausea and vomiting of pregnancy is a great moment for me and the entire team. It will be one of my most significant professional accomplishments.” stated
A total of 280 pregnant women with morning sickness were randomized to receive either Diclectin(R) or a similar appearing Placebo. The group receiving Diclectin(R) experienced greater improvement of morning sickness symptoms and quality of life, and shorter loss of time from work. Significantly more women receiving Diclectin(R) asked to continue it after the 2 week trial, as compared to the Placebo group.
“With the very wide maternal-fetal safety record of this drug combination, unmatched by any previous drug on the market, we hope that very soon American women will benefit from a safe and effective drug for morning sickness after 30 years of being orphaned from such medication” said Dr.
Reference: Effectiveness of delayed-release doxylamine and pyridoxine for nausea and vomiting of pregnancy: a randomized placebo controlled trial. American Journal of Obstetrics and Gynecology 2010. ajog.org (http://www.ajog.org/article/S0002-9378(10)00914-2/abstract)
SOURCE Duchesnay inc.