First UK Licensed Treatment for Nausea and Vomiting of Pregnancy

Theresa Bebbington

October 04, 2018

Up to 80% of pregnant women experience nausea and vomiting of pregnancy (NVP), according to the Royal College of Obstetricians and Gynaecology (RCOG), and the condition is one of the most common reasons pregnant women are hospitalised. NVP can take its toll on a woman's quality of life and mental health. Persistent nausea can make it difficult to eat healthily, lead to taking time off work and affect a woman's ability to care for her family.

Conservative management of NVP – such as a change in diet, getting plenty of rest and other non-medical treatments – should be the first approach for treatment. However, for women who continue to experience NVP after following these measures, Xonvea can now be prescribed in the UK if the woman is 18 years of age or older. 
 

New Drug

Xonvea is the brand name of a gastro-resistant tablet that contains 10 mg doxylamine succinate (an antihistamine) and 10 mg pyridoxine hydrochloride (vitamin B6). The doxylamine/pyridoxine combination was previously in-licensed from Duchesnay Inc. of Canada for the UK in 2015, and it has already been available to more than 30 million women in the USA and Canada (prescribed as Diclegis/Diclectin, among other brand names). 

Xonvea was approved by the MHRA for marketing in the UK in July 2018, and the British-based pharmaceutical company Alliance Pharma has made the product available in the UK from 2 October 2018. Alliance Pharma's chief executive Peter Butterfield noted, "there is no other licensed treatment for nausea and vomiting of pregnancy in the UK".
 

Welcome News

Clare Murphy, director of external affairs at the British Pregnancy Advisory Service (BPAS), said: "We welcome the news that finally a licence has been granted for a medication to treat nausea and vomiting in pregnancy. We know that many women are simply told to put up with debilitating symptoms on the basis that no medication is safe in pregnancy, when in fact the risks of not treating may be significantly higher. Our hope is that a licensed product will give doctors confidence to prescribe for women who need it."

The RCOG also welcomes Xonvea for treating NVP, describing it as "a significant step forward". Dr Patrick O’Brien, consultant obstetrician and spokesperson for the organisation, said:"Previously, a variety of anti-sickness medicines were offered, none of which were licensed for use in pregnancy, but were considered safe as there was no evidence that they caused any harm to the baby.

"Xonvea medication should now be used as a frontline treatment for women with nausea and vomiting during pregnancy. It may also be useful in treating women with hyperemesis gravidarum – a severe form of nausea and vomiting in pregnancy that leads to dehydration and a significant weight loss – in combination with other anti-sickness medications."
 

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