following a full submission:
cenobamate (Ontozry®) is accepted for restricted use within NHSScotland.
Indication under review: for the adjunctive treatment of focal-onset seizures with or without secondary generalisation in adult patients with epilepsy who have not been adequately controlled despite treatment with at least 2 anti-epileptic medicinal products.
SMC restriction: in patients with drug-resistant epilepsy as a second-line adjunctive anti-seizure medicine, after the failure of the first adjunctive anti-seizure medicine.
In patients with uncontrolled focal seizures, despite treatment with anti-epileptic medicines, cenobamate was superior to placebo in terms of the proportion of patients experiencing a ≥50% reduction in focal seizure frequency.
Medicine details
- Medicine name:
- cenobamate (Ontozry)
- SMC ID:
- SMC2408
- Indication:
For the adjunctive treatment of focal onset seizures (FOS) with or without secondary generalisation in adult patients with epilepsy who have not been adequately controlled despite treatment with at least two anti-epileptic products.
- Pharmaceutical company
- Arvelle Therapeutics, A Angelini Pharma Group Company
- BNF chapter
- Central nervous system
- Submission type
- Full
- Status
- Restricted
- Date advice published
- 07 February 2022