Duchesnay wins US FDA OK for morning sickness drug Diclegis
This article was originally published in Scrip
Duchesnay won the US FDA's approval to market Diclegis (doxylamine succinate 10mg, pyridoxine hydrochloride 10mg) delayed-release tablets as a therapy for nausea and vomiting related to pregnancy in women who do not respond to conservative management.
The drug is the first medicine approved in more than three decades in the US to treat morning sickness, the symptoms of which some women experience throughout their pregnancy, although for most women, the symptoms generally cease at about 16-20 weeks.
Up to 85% of pregnant women have symptoms of morning sickness that range from nausea to severe vomiting and retching.
The two active ingredients in Diclegis– doxylamine succinate and pyridoxine hydrochloride, or vitamin B6 – have been recommended over the past nine years as a first-line pharmacotherapy to reduce nausea and vomiting in pregnancy in guidelines from the American Congress of Obstetricians and Gynecologists.
Diclegis is intended to be taken daily on an empty stomach.
The recommended starting dose is two tablets taken at bedtime. If symptoms are not adequately controlled, the dose can be increased to a maximum recommended dose of four tablets daily – one in the morning, one mid-afternoon and two at bedtime.
The FDA said health care professionals should reassess their patients for continued need for Diclegis as pregnancy progresses.
Drowsiness or sleepiness, which can be severe, is the most common adverse effect reported by women taking Diclegis, regulators noted, adding that women should avoid using the medicine when engaging in activities requiring mental alertness, such as driving or operating heavy machinery, until cleared to do so by their health care provider.
Duchesnay noted that the FDA granted Diclegis Pregnancy Category A status, which means the results of controlled studies have not shown an increased risk to an unborn baby during pregnancy.
Diclegis was studied in 261 women experiencing nausea and vomiting due to pregnancy. Study participants in the trial were at least 18 years old and had been pregnant for at least 7 weeks and up to 14 weeks.
Women were randomly assigned to receive two weeks of treatment with Diclegis or a placebo.
The study results showed that women taking Diclegis experienced greater improvement in nausea and vomiting than those taking placebo.
Duchesnay said it expects to make Diclegis widely available in the US by the end of next month.