Article Text
Abstract
Background Nausea and vomiting of pregnancy (NVP) affect almost pregnancies. The only agent approved by the FDA and other countries for the management of NVP symptoms has been the delayed release combination of doxylamine and pyridoxine. This combination, formulated as a 10 mg/10 mg delayed release tablet, was approved by the FDA for the treatment of NVP in 2013 (Diclegis®).
Due to its delayed release properties, Diclegis® begins to exert its antiemetic properties 6–8 hours after ingestion, and hence symptom relief may be delayed and necessitate the use of an immediate release medication.
Methods In 2016 the FDA approved Bonjesta®, a novel, dual- release combination of doxylamine and pyridoxine, whereby a rapid release phase is followed by a delayed release phase, thus overcoming the time delay in action of Diclegis®. Bonjesta®, is a multilayer, extended-release tablet consisting of an enteric-coated core containing 10 mg doxylamine succinate and 10 mg pyridoxine hydrochloride, and an immediate-release coating of 10 mg doxylamine succinate and 10 mg pyridoxine hydrochloride, delivering a total of 20 mg doxylamine succinate and 20 mg pyridoxine hydrochloride
Results In a single-and multiple dose study in 48 healthy, premenopausal women, one Bonjesta® (20 mg doxylamine succinate and 20 mg pyridoxine) was bioequivalent to two combination tablets of 10 mg doxylamine succinate and 10 mg pyridoxine hydrochloride
Bonjesta has shown an immediate peak concentrations, followed by a delayed release phase.
Conclusions The combination of the immediate release with a delayed action is unique to Bonjesta® as it allows for the bedtime dose to be effective immediately and also provide with sustained control of NVP symptoms throughout the day.
Disclosure(s) G Koren has been a consuntant for Duchesnay Inc.