About Xonvea®
Xonvea® is the only licensed treatment of nausea and vomiting of pregnancy (NVP) in the UK.1
The 2024 RCOG Guidelines recommend Xonvea® as a first-line treatment option for NVP.2
615,525 pregnancies with Xonvea®
615,525 the number of pregnancies in which Xonvea® has been prescribed (global usage data for the three years Feb 2020 – Jan 2023).3
~70 years of NVP experience
Xonvea® is backed by ~70 years of global experience with the use of doxylamine/pyridoxine combination products to treat NVP, with the first combination product introduced in 1956.4
Xonvea®: Your Treatment Option for NVP
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How to take Xonvea®1
Xonvea® has a gradual, step-up dosing regimen.
Regular Review and Gradual Discontinuation of Xonvea®
The continued need for Xonvea® should be assessed regularly throughout pregnancy. To prevent a sudden return of NVP symptoms, a gradual tapering dose of Xonvea® is recommended at the time of discontinuation.1
Daily Use Instructions for Xonvea®
Xonvea® should be taken regularly as a daily prescription (not as needed), on an empty stomach with a glass of water. The tablets should be swallowed whole and should not be crushed, split, or chewed.1
Xonvea® Phase 3 Clinical Trial
The safety and efficacy of Xonvea® were established in a Phase 3, multicentre, randomised, double-blind, placebo-controlled study conducted over a 15-day period in pregnant women (n=131 Xonvea®; n=125 placebo), taking 2 doses daily at bedtime and increasing to a maximum of 4 doses daily where indicated.5
Patient population
- Women > 18 years of age
- Gestational age 7-14 weeks (mean 9.3 weeks)
- PUQE score ≥ 6, no response to conservative management (dietary lifestyle).
- Women on anti-emetics/chronic medical conditions were excluded
Symptom control endpoint
- Primary effectiveness endpoint: The mean difference in PUQE score from baseline to Day 15.
- Subjects completed PUQE score & the global assessment of well-being scale on Days 1, 8, and 14.
Quality of life endpoint
- Secondary effectiveness endpoint: The change from baseline to Day 15 in global assessment of well-being score.
Xonvea® Symptom Control
The primary endpoint was met – demonstrating a reduction in PUQE symptom domain score from baseline compared to placebo at Day 15 (p=0.006).5
Xonvea® can help manage the symptoms of NVP if conservative management has failed.5
Xonvea® Quality of Life
The quality-of-life endpoint was also met – demonstrating a significant increase in global assessment of well-being score from baseline compared to placebo (p = 0.005) at Day 15.5
- There was a trend towards less time lost from work in Xonvea® group (0.92 ± 3.85) compared to placebo (2.37 ± 10.23) (p = 0.06; non-significant).5
- Women receiving placebo were 50% more likely to report use of alternate therapies or dietary modification, as compared with women receiving Xonvea® (36% women on placebo, 23.7% on Xonvea®, p = 0.04).5
- Significantly more women in the Xonvea® group (48.9%) asked to continue compassionate use following the 15-day study period than in the placebo group (32.8%) (p = 0.009).5
Understanding Xonvea® Safety and Tolerability
Xonvea® has demonstrated an acceptable tolerability profile.1
Xonvea® was generally well-tolerated by participants during clinical trials. The most common reported adverse events (AEs) in long-term clinical trials of treatment with Xonvea® were somnolence, dizziness, dry mouth and fatigue.1
Abbreviations: NVP, Nausea and vomiting of pregnancy; ; RCOG, Royal College of Obstetricians and Gynaecologists; PUQE, Pregnancy-Unique Qualification of Emesis PUQE,; ITT, Intention-to-Treat; AEs, Adverse Events.
References: 1. XONVEA® Summary of Product Characteristics. 2. Nelson-Piercy et al; Royal College of Obstetricians and Gynaecologists. The Management of Nausea and Vomiting in Pregnancy and Hyperemesis Gravidarum (Green-top Guideline No. 69). BJOG. 2024. 3. Exeltis data on file XON03. 4. Madjunkova, S., et al. Paediatr Drugs. 2014;16:199-211. 5. Koren, G., et al. Am J Obstet Gynecol. 2010. 203(6): 571.e1-571.e7.
