Novartis' Ritalin LA cleared in USA

Novartis' longer-acting attention deficit/hyperactivity disorder drugRitalin LA (methylphenidate) has been approved by the US Food and Drug Administration. Ritalin LA, which extends the company's ADHD franchise from its existing immediate-release Ritalin product, is designed to help Novartis cope with competition in the sector from a slew of new once-daily ADHD products, including Shire Pharmaceuticals' Adderall XR (mixed amphetamines) and Alza's Concerta (methylphenidate; Marketletters passim).

The benefits of once-daily administration rest on the fact that a dose does not have to be given during the school day. Ritalin LA is available in 20mg, 30mg and 40mg beaded capsules and was developed using Elan Corp's SODAS drug delivery technology, which combines immediate-release particles, to provide a rapid onset of action, with gradual-release particles to maintain the control of ADHD symptoms throughout the day. Novartis' ADHD franchise also includes a sustained-release version of the drug (Ritalin SR) and Focalin (dexmethylphenidate HCl). Both Ritalin LA and Focalin are licensed from Celgene.

Commenting on the approval, analyst Denise Anderson at Julius Baer noted that Novartis' sales of Ritalin have been in decline due to competition from both generics and newer drugs from rival firms. "We expect that the approval of Ritalin LA will temporarily halt this decline but forecast that this area will not be an important growth driver for Novartis," she added.