Duchesnay’s Bonjesta is indicated for the treatment of nausea and vomiting of pregnancy (“NVP”) in women who do not respond to conservative management.
NVP, commonly known as morning sickness, is a medical condition that affects up to 85 percent of pregnant women. NVP can be different for each woman, with symptoms including: nausea, gagging, retching, dry heaving, and vomiting. For most pregnant women, symptoms generally cease at approximately 14 to 16 weeks.
However, some women can experience symptoms throughout their pregnancy. Impacts of NVP also include economic burdens, with NVP being directly linked to hospitalization, emergency room visits and time lost from work among employed women. NVP is also linked to instances of restricted activity and impaired job performance.
“Duchesnay is pleased to provide a multilayer extended-release treatment for expectant mothers to effectively and easily manage morning sickness symptoms throughout the day and night,” said Éric Gervais, executive vice-president of Duchesnay, Inc. “The combination of ingredients found in Bonjesta is a proven NVP treatment option with a 60-year safety record of use in market for millions of mothers and their babies, globally.”
Bonjesta received FDA approval in 2016 based on the safety and efficacy data from Diclegis (doxylamine succinate and pyridoxine hydrochloride) delayed-release tablets, and three clinical pharmacology studies: a single-dose bioequivalence study, a multiple-dose bioequivalence study and a food-effect study.
Bonjesta is a multilayer, extended-release formulation that is designed to provide both fast-acting and long-lasting symptom relief. A reduced pill burden (maximum daily dose of two tablets) could also improve patient adherence.
The American College of Obstetrics and Gynecology (ACOG) recommends the combination of ingredients in Bonjesta as first-line pharmacotherapy for the treatment of NVP after conservative management has failed.
Bonjesta will have dedicated affordability programs, including copay assistance and a dedicated patient assistance program for patients in need.
(Source: Duchesnay USA, Inc.)
Filed Under: Drug Discovery