UCB announced has won approval for its attention deficit hyperactivity drug Equasym XL across the European Union via the mutual recognition procedure.
The UK acted as the reference member state for the MRP, and other EU countries are expected to issue marketing authorisations for the product over the coming months.
Equasym XL (methylphenidate) was launched in the UK, its first European market, in 2005. The product has been sold in the USA under the Metadate CD brand name since 2001, where it has a market share of around 3%, and has also been approved in Finland.
The capsule product uses a drug delivery technology developed by Eurand which provides eight-hour cover of ADHD symptoms, in other words it delivers the active drug during school hours when the need is greatest.
Clinical trial data suggest that Equasym XL may be more effective in controlling ADHD symptoms than the leading once-daily methylphenidate product, Johnson & John’s Concerta, during the morning hours, according to Datamonitor.
- In a separate announcement, UCB said it has reached agreement for Adams Respiratory Therapeutics to sell its over-the-counter cough suppressant liquid Delsym for an upfront fee of $122 million, as well as royalties on sales and a manufacturing supply contract.