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 12-week, randomised, placebo-controlled, double-blind Phase 3 studies, followed by a 40-week extension no-control treatment period.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

Liver Function tests (LFTs) must be performed prior to treatment initiation with VEOZA and monthly during the first three months of treatment, then based on clinical judgement.

VEOZA has once-daily oral dosing. The recommended dose of VEOZA is 45 mg taken orally with or without food. Take with liquids and swallow whole. Do not break, crush, or chew tablets.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.

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

Treatment should be discontinued in the following situations:

• Transaminase elevations are ≥ 3 x upper limit of normal (ULN) with: total bilirubin > 2 x ULN OR symptoms of liver injury.
• Transaminase elevations > 5 x ULN.

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

Please refer to the SmPC for the full safety profile.