VEOZA is not a hormone. It blocks neurokinin B (NKB) binding on the kisspeptin/neurokinin B/dynorphin (KNDy) neuron, which is postulated to restore the balance in KNDy neuronal activity in the thermoregulatory centre of the hypothalamus.^1,3,4

The efficacy of VEOZA was evaluated in two identical, randomised, placebo-controlled, double-blind 12-week Phase 3 studies (SKYLIGHT 1 and SKYLIGHT 2), followed by a 40-week extension no-control treatment period. The co-primary endpoints were change from baseline in moderate to severe VMS frequency and severity to weeks 4 and 12.¹ The studies consisted of postmenopausal women with a minimum average of 7 moderate to severe VMS per day.¹

VEOZA met all primary endpoints within the SKYLIGHT 1 and SKYLIGHT 2 Phase 3 trials. Patients taking VEOZA experienced a statistically significant reduction from baseline in VMS frequency and severity over 24 hours at Weeks 4 and 12, compared to placebo.¹

VEOZA has once-daily oral dosing. The recommended dose of VEOZA is 45 mg taken orally with or without food and taken with liquids. Tablets are to be swallowed whole and not broken, crushed or chewed.¹

Patients should take VEOZA at about the same time each day. If a dose is missed or not taken at the usual time, patients should take the missed dose as soon as possible on the same day, unless there are fewer than 12 hours before the next scheduled dose. Patients/individuals should return to the regular schedule the following day.¹

Liver function tests (LFTs) must be performed prior to treatment initiation with fezolinetant.
Treatment should not be started if ALT or AST is ≥ 2 x ULN or if total bilirubin is elevated (e.g., ≥ 2 x ULN). LFTs must be performed monthly during the first three months of treatment, then based on clinical judgement. LFTs must also be performed when symptoms suggestive of liver injury occur. Patients should be informed about the signs and symptoms of liver injury and should be advised to contact their doctor immediately once these occur.¹

In the case of overdose, the individual should be closely monitored, and supportive treatment should be considered based on signs and symptoms.¹

Please refer to the SmPC for full information on dosing and administration.

Across the Phase 3 studies, the most common adverse reactions with VEOZA were diarrhoea (3.2%) and insomnia (3.0%). The most frequent adverse reactions leading to dose discontinuation with VEOZA were alanine aminotransferase (ALT) increased (0.3%) and insomnia (0.2%).¹

There were no serious adverse reactions reported at an incidence greater than 1% across the total study population.¹

Four serious adverse reactions were reported. The most serious adverse reaction was an event of endometrial adenocarcinoma (0.1%).¹

Elevations in ALT levels > 3 x ULN occurred in 2.1% of women receiving fezolinetant compared to 0.8% of women receiving placebo. Elevations in AST levels > 3 x ULN occurred in 1.0% of women receiving fezolinetant compared to 0.4% of women receiving placebo.
Serious cases with elevations of ALT and/or AST (> 10 x ULN) with concurrent elevations in bilirubin and/or alkaline phosphatase (ALP) were reported post-marketing. In some cases, elevated liver function tests were associated with signs and symptoms suggestive of liver injury such as fatigue, pruritus, jaundice, dark urine, pale faeces, nausea, vomiting, decreased appetite, and/or abdominal pain.¹

Please refer to the SmPC for the full safety profile.