IQVIA Holdings ((IQV)) announced an update on their ongoing clinical study.
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Study Overview: The QUVIVIQ® Pregnancy Registry, officially titled ‘Registry to Collect Information on Pregnancy, Neonatal, and Infant Outcomes in Pregnant Women Exposed to QUVIVIQ®,’ aims to explore the effects of QUVIVIQ exposure on pregnancy, neonatal, and infant outcomes. This study is significant as it seeks to provide insights into the safety and implications of using QUVIVIQ, a treatment for insomnia, during pregnancy.
Intervention/Treatment: The study investigates the effects of the drug Daridorexant, marketed as QUVIVIQ, which is used to treat insomnia. It compares outcomes in women exposed to QUVIVIQ during pregnancy with those exposed to other insomnia medications or none at all.
Study Design: This is an observational cohort study. It does not involve random allocation or masking, focusing instead on real-world outcomes. The primary purpose is to observe and compare the effects of different insomnia treatments during pregnancy.
Study Timeline: The study began on June 17, 2024, with the latest update submitted on December 13, 2024. These dates are crucial as they mark the progress and ongoing nature of the study, which is expected to continue for 21 months.
Market Implications: This study update could influence investor sentiment and stock performance for Idorsia Pharmaceuticals Ltd., the lead sponsor, as it may impact the perceived safety and marketability of QUVIVIQ. Competitors in the insomnia treatment market may also be affected, depending on the study’s findings.
The study is ongoing, with further details available on the ClinicalTrials portal.