Tuzulby

Tuzulby is a drug for which a marketing authorization application was submitted on 24 November 2022, with eligibility for the centralised procedure agreed by EMA/CHMP on 22 July 2021. The CHMP issued a positive opinion for granting marketing authorisation on 12 December 2024, recommending the granting of marketing authorisation. The reference product was authorized on 15 January 1997. Tuzulby has a shelf-life of 3 years.

In terms of efficacy, Tuzulby demonstrated statistically significantly lower SKAMP-Combined scores compared to placebo at 0.75, 2, 4, and 8 hours post-dose. The change from placebo in SKAMP-Combined score (LS mean) was -7.0, with the SKAMP-Combined score (LS mean) for NWP09 being 12.1 compared to 19.1 for placebo (P-value <0.001). In the clinically evaluable population, the change from placebo was -5.8, with NWP09 showing a score of 12.3 versus 18.1 for placebo (P-value 0.003). Non-inferiority comparison results for ER formulations versus IR Ritalin were supported.

Safety findings from Study 2021-5129, an open-label, single-dose, randomised, two-period, two-treatment, crossover, comparative bioequivalence study in 24 adult healthy volunteers, indicated that 45.8% of subjects experienced treatment-emergent adverse events (TEAEs). Drug-related TEAEs were experienced by 21.7% of subjects with Treatment A and 33.3% with Treatment B. Headache was reported by 20.8% of subjects, and tachycardia by 4.2%.