ENSVA

What it is

ENSVA contains prucalopride as the succinate salt, available as film-coated tablets in 1 mg and 2 mg strengths. Prucalopride is a drug acting on serotonin receptors (ATC code A03AE04).

Approved indications

— Chronic functional constipation in adults in whom laxatives fail to provide adequate relief. Before ENSVA is considered, patients must have tried at least two different types of laxatives from different classes at the highest tolerated recommended doses for at least six months without adequate relief from constipation. If treatment with ENSVA is not effective within four weeks, the benefit of continuing treatment should be reconsidered.

Dosing overview

The standard adult dose is 2 mg once daily. ENSVA tablets are for oral use and can be taken with or without food. If the intake of the prescribed once daily dose is not effective after four weeks of treatment, the patient should be re-examined and the benefit of continuing treatment should be reconsidered. Patients should be reassessed after 12 weeks prior to continuation of treatment. ENSVA is not recommended in children and adolescents younger than 18 years.

Key safety warnings

ENSVA should be used with caution in patients with a history of arrhythmias or ischaemic cardiovascular disease. ENSVA should be used with caution in patients receiving concomitant drugs known to cause QTc prolongation. Suicides, suicide attempts, and suicidal ideation have been reported in clinical trials and post-market experience. Patients should be monitored for persistent worsening of depression or the emergence of suicidal thoughts and behaviours. Counsel the patients and their caregivers and family members to be aware of any unusual changes in mood or behaviour, and to discontinue ENSVA and alert the healthcare provider immediately. The most frequently reported adverse reactions are headache and gastrointestinal symptoms (abdominal pain, nausea or diarrhoea) occurring in approximately 20% of patients each. These adverse reactions occur predominantly at the start of therapy and usually disappear within a few days with continued treatment. Prucalopride has been associated with dizziness and fatigue particularly during the first day of treatment which may have an effect on driving and using machines. In case of severe diarrhoea, the efficacy of oral contraceptives may be reduced and the use of an additional contraceptive method is recommended to prevent possible failure of oral contraception.

Contraindications

ENSVA is contraindicated in patients with hypersensitivity to the active substance or to any of the excipients, renal impairment requiring dialysis, intestinal perforation or obstruction due to structural or functional disorder of the gut wall, obstructive ileus and active severe inflammatory conditions of the intestinal tract such as Crohn's disease and ulcerative colitis and toxic megacolon/megarectum, and recent bowel surgery.

Regulatory history

ENSVA was first listed on the Australian Register of Therapeutic Goods on 17 October 2025. The date of first approval was 17 October 2025.