Neuraxpharm — Tuzulby EMA EPAR variation assessment report (EMEA/H/C/005975, 2025)
Neuraxpharm · 2025 · EMA EPAR variation assessment report
Report summary
The EMA assessed Neuraxpharm's Tuzulby (methylphenidate hydrochloride) extended-release chewable tablets for pediatric ADHD, granting a positive marketing authorization opinion on December 12, 2024. The application, referencing Ritalin 10 mg, was supported by comprehensive quality, non-clinical, and clinical data. Pharmacokinetic studies demonstrated dose proportionality and bioequivalence. Clinical efficacy, shown by significant improvement in SKAMP-Combined scores, was maintained for up to 8 hours, with non-inferiority to Ritalin IR. Safety data indicated similar adverse event rates to placebo in the double-blind phase, with decreased appetite and mood swings common in the open-label phase. Key safety concerns include cardiovascular events, psychosis, tics, aggression, and growth reduction. The CHMP concluded a positive benefit-risk balance.
Key findings — cited to the page
| Number of subjects randomized and enrolled in Study 2021-5129 | 24 subjects | Study 2021-5129 (LESVIMETHYL/21/BQ-9) · p.23 |
| Study population | adult healthy volunteers | LESVIMETHYL/21/BO-9 (Study 2021-5129) · p.80 |
| Study type | open label, single dose, randomised, two-period, two-treatment, crossover, comparative bioequivalence study | LESVIMETHYL/21/BO-9 (Study 2021-5129) · p.80 |
| Marketing authorization application submission date | 24 November 2022 | Tuzulby · p.5 |
| Eligibility to centralised procedure agreed by EMA/CHMP | 22 July 2021 | · p.5 |
| Reference product authorization date | 15-01-1997 | Ritalin 10 mg Tabletten · Germany · p.6 |
| CHMP positive opinion for granting marketing authorisation | 12 December 2024 | Tuzulby · p.8 |
| Tuzulby immediate release component | 30 % of the dose | Tuzulby · p.13 |
| Tuzulby prolonged-release component | 70 % of the dose | Tuzulby · p.13 |
| Tuzulby therapeutic plasma levels duration | 8 hours | Tuzulby · p.13 |
| Shelf-life | 3 years | Tuzulby · p.15 |
| Subjects experiencing TEAEs in Study 2021-5129 | 11 subjects | Study 2021-5129 (LESVIMETHYL/21/BQ-9) · p.27 |
Source: Neuraxpharm ↗ · License: EMA - reuse permitted with acknowledgement. Summary and findings are extracted from the published document; every figure cites its page. Informational only — not investment advice. Explore the Psychiatry library →