Treating Symptoms of Morning Sickness: The First Dual Release Combination of Doxylamine-Pyridoxine

Gideon Koren1*, Manon Vrandrick2

Modified release tablet preparations are sought when there is a need to provide clinical solutions which are not achieved optimally with the standard release products. Nausea and vomiting of pregnancy (NVP) affect most pregnancies. Symptomatic treatment aims to improve woman’s quality of life, and counteract dehydration, electrolyte imbalance, need for hospitalization and attendant risk of maternal and fetal complications. Until recently, the only agent approved by Canada, USA, South Korea. Israel and Singapore has been the delayed release combination of doxylamine and pyridoxine (Diclectin®/ Diclegis®).
All other countries worldwide do not presently have a pregnancy- approved anti emetic drug. Due to its delayed release properties, Diclectin®/ Diclegis® begins to exert its antiemetic effect 6-8 hours after ingestion, and hence symptom relief may be delayed and necessitate the use of an immediate release medication. In November 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 the delayed release combination of doxylamine and pyridoxine. In this article we review the unique properties of this new drug in the context of other medications where modified- release forms have been effective.