A prescription morning sickness drug combining doxylamine succinate and pyridoxine hydrochloride is returning to US pharmacies after a thirty-year absence. The 21st-century iteration, named Diclegis, is produced by Duchesnay and is the only FDA-approved medication for morning sickness.
“Many people see it as a rite of passage,” Shannon Clark, Associate Professor, Division of Maternal and Fetal Medicine, University of Texas medical branch, said of morning sickness during a press presentation. But Clark said the impact—which can include dry heaves and nausea—goes beyond discomfort and can force expectant mothers to miss work and interfere with everyday activities. Clark estimated that around 80% of pregnant women experience some form of morning sickness.
While some patients have tried making their own variation using over-the-counter medications, one drawback, in addition to inconsistent dosing, was that homemade solutions included unnecessary ingredients. “It’s hard enough to take one pill, let alone two” when struggling with nausea and vomiting, said Clark.
Diclegis is a new version of Bendectin, which was pulled amid worries about birth defects. The FDA did not find a link between the drug and birth defects, but litigation costs ate into then-producer Merrell Dow’s ability to make the drug. Duchesnay USA CEO Gilbert Godin told MM&M that despite the market absence, the company does not have to contend with a negative image of the drug. Instead, he said, healthcare practitioners either have no memory of its predecessor or “can relate very strongly and very positively to Bendectin, and they can really tell you how much they used it.” Godin said the reintroduction is further bolstered by the drug’s continued use in Canada, which means a backlog of three decades of history and opinion is just across the border. Godin said his company was pugnacious about bringing this drug back to the US market
“I think very few people realize that it’s not as simple as it seems,” and that navigating the regulatory complexity and cost required the family-owned company to dedicate a lot of time “against all odds.”
While Kate Middleton could be considered the go-to example for the condition, she would not be the target audience: Middleton suffered from an extreme condition the drug is not meant to combat.
Godin said the May launch will include a sales force that will reach 90 to 100 sales territories and will focus on obstetricians, nurse practitioners and midwives. The company has also been working with payers, and says it’s been trying to get the drug to be priced at about $1 a day. The drug is meant to be taken daily, with a dosing that can be stepped up as needed, but begins with a nighttime regimen. Although the manufacturer is courting healthcare providers, Godin said that once the consumer component launches he does expect demand to be patient-driven.
