Neuraxpharm Receives EU Approval for Tuzulby, an ADHD Treatment, Launching Commercialization in Europe
Approval and Commercialization
The European Commission approved Tuzulby (methylphenidate hydrochloride) from Neuraxpharm Pharmaceuticals on February 28, 2025. The CHMP (Committee for Medicinal Products for Human Use) under the European Medicines Agency (EMA) adopted a positive opinion on December 12, 2024, and the approval applies throughout the EU. The product was launched in Europe in January 2026, transitioning from a clinical-stage product to a marketed product. The indication is for the comprehensive treatment of ADHD in children and adolescents aged 6-17 years when non-pharmacological interventions alone are not sufficient.
Drug and Clinical Evidence
Tuzulby is a central nervous system stimulant that inhibits dopamine transporter (DAT) and norepinephrine transporter (NET). It is administered as a 20mg, 30mg, and 40mg extended-release chewable tablet. The EMA approved the hybrid drug based on a pharmacokinetic comparison with the reference drug Ritalin (methylphenidate hydrochloride) and a placebo-controlled classroom study in pediatric patients. In this study, the mean SKAMP total score change from baseline was 12.1 for the Tuzulby group and 19.1 for the placebo group, with a treatment difference of -7.0 (p < 0.001). The effect was statistically significant from 0.75 hours to 8 hours after administration, demonstrating the value of the formulation for covering most of the school day, starting from the beginning of the school day.
Competitive Landscape and Differentiation
The direct competitors are long-acting stimulants such as Concerta (methylphenidate hydrochloride, Janssen), Ritalin (methylphenidate hydrochloride, Novartis), and Medikinet (methylphenidate hydrochloride). Other competing drugs with different mechanisms of action include Elvanse (lisdexamfetamine dimesylate, Takeda), which increases dopamine and norepinephrine release, Strattera (atomoxetine), a selective norepinephrine reuptake inhibitor, and Intuniv (guanfacine, Takeda), an alpha2A adrenergic receptor agonist. The key differentiator for Tuzulby is not a new active ingredient, but rather a once-daily extended-release chewable formulation targeted at children and adolescents who have difficulty swallowing. Therefore, ease of administration and convenience of dosage adjustment are key drivers for prescription conversion, rather than superior clinical efficacy.
Market and Business Structure
Market research firm Market Data Forecast estimates the European ADHD treatment market at USD 3.71 billion in 2025 and USD 7.47 billion in 2034, with a compound annual growth rate of 8.1% from 2026 to 2034. Tuzulby is a LiquiXR-based product developed by Tris Pharma as QuilliChew ER in the United States, and the FDA approved the same active ingredient and formulation on December 4, 2015. Neuraxpharm secured regional rights through an exclusive commercialization agreement signed in 2020 and has expanded the proven formulation from the United States to a European revenue source with EMA approval. However, in the mature methylphenidate market, national pricing and reimbursement, and the maintenance of a premium over generic drugs will determine the speed of commercial penetration.
Tuzulby's approval as a marketed product provides Neuraxpharm with a foothold in the USD 3.71 billion European ADHD treatment market in 2025, targeting the niche market of chewable extended-release formulations for children. In the short term, ease of swallowing and significant symptom control for up to 8 hours will be key factors in determining adoption rates compared to methylphenidate formulations such as Concerta, Ritalin, and Medikinet. In the medium to long term, national reimbursement listings and price premiums over generics will be key variables in expanding sales, including competition from Elvanse and non-stimulant drugs such as Strattera and Intuniv. For researchers, it is a case study demonstrating that drug delivery and formulation innovation can improve the lifecycle and patient compliance of existing CNS assets. For the industry, it presents a capital-efficient expansion model in which Tris Pharma's US-approved asset is linked to EU approval and commercialization by a regional partner.
Source: EMA (ema)