Rx aid for morning sickness makes return after 30 years
OPDP not happy with Diclegis promo
A prescription morning sickness drug combining doxylamine succinate and pyridoxine hydrochloride is returning to US pharmacies after a 30-year absence. The 21st-century iteration, 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, asn associate professor in the division of maternal and fetal medicine at the University of Texas, said of morning sickness during a press presentation. But Clark said its impact can interfere with everyday activities. Clark estimated that around 80% of pregnant women experience some form of morning sickness.
Diclegis is a new version of Bendectin, which was pulled due to worries about birth defects. The FDA found no 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 don't remember 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 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.