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Adalvo announces successful European approval for Lisdexamfetamine Oral Solution

13 February 2024

Adalvo is delighted to announce the successful DCP approval for Lisdexamfetamine Oral Solution 10mg/ml, developed in close collaboration with one of our strategic partners.

This product represents a value-added version of Lisdexamfetamine Hard Capsules, available in the form of a taste-masked, ready-to-use oral solution. Targeting a child-friendly approach, our solution is a repurposed iteration of Elvanse, a CNS drug indicated for the treatment of Attention Deficit Hyperactivity Disorder (ADHD).

Lisdexamfetamine INN had a total global sales of $5.25bn in 2022 with a 3Y CAGR of 5%, according to IQVIA.

Adalvo's Lisdexamfetamine Oral Solution (OS) stands as the first and only approved European product in its category. As of today, Adalvo is the only company that can offer approved Lisdexamfetamine Capsules and Oral Solution. This achievement underscores our commitment to enhancing patient value and reaffirms our dedication to delivering innovative and differentiated products to our valued partners.

Adalvo anticipates being the first company to market this value-added product on Day 1 in all major markets.

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