Novartis has won US approval for Focalin XR (dexmethylphenidate), a new once-daily version of its fast-acting attention deficit hyperactivity disorder drug Focalin, developed alongside Celgene and first introduced in 2001.

For children with ADHD, once-daily dosing is compelling because it eliminates the stigma of taking medication during the school day, while controlled-release formulations are generally believed to give more consistent control over their symptoms.

Dexmethylphenidate is the d- or ‘right-handed’ isomer of the racemic mixture found in Novartis’ original ADHD treatment Ritalin (methylphenidate). It offers a quicker onset of action than the racemate, and is equally effective at half the dose.

In the early 1990s, Novartis had the ADHD marketplace to itself with its three-times-daily Ritalin product, although generic competition appeared in the latter half of the decade. Since then, a raft of rival drugs with once-daily dosing, such as Shire Pharmaceuticals’ Adderall XR (mixed amphetamine salts) and Johnson & Johnson’s Concerta (methylphenidate), have reached the market.

Novartis responded by launching once-daily Ritalin formulations (Ritalin LA). However, Focalin’s twice-daily dosing meant that it lacked a key competitive edge, despite its improved therapeutic profile. That changes with the launch of the once-daily version.

Analysts said Focalin XR is a modest improvement over current ADHD drugs, particularly with regard to its rapid onset of action, but with generic versions of once-daily Adderall XR and Concerta already nearing the US market [[08/12/04e]] its growth potential is limited.