Marketing clearance for Ritalin LA once-daily formulation

Marketing clearance for Ritalin LA once-daily formulation

EAST HANOVER, N.J., DUBLIN, IRELAND & WARREN, N.J. -- Novartis Pharmaceuticals,  Elan Corporation, and Celgene Corporation announced that the FDA has granted marketing clearance for Ritalin LA (methylphenidate HCl) extended-release capsules for the treatment of attention-deficit/hyperactivity disorder (ADHD).

Ritalin LA is a new, once-daily formulation of Ritalin that eliminates the need for a midday dose during school. Ritalin LA uses SODAS technology(1), a proprietary drug delivery technology from Elan. The medication is available in 20, 30 and 40 mg beaded capsules for oral administration.

"Ritalin LA represents an important advance in the treatment of ADHD," said Thomas Spencer, M.D., Associate Professor of Psychiatry, Harvard Medical School and Assistant Director of the Pediatric Psychopharmacology Research Program at Massachusetts General Hospital. "It provides the rapid onset, and the proven safety and efficacy of Ritalin in one, single morning dose. Ritalin LA is effective in treating ADHD symptoms throughout the school day, eliminating the need for children to take their medication while in school."

Each bead-filled capsule of Ritalin LA provides an immediate release of Ritalin for rapid onset of action, and a second release of the medication approximately four hours after administration. The bimodal release formulation of Ritalin LA provides two peak concentrations of medication, mimicking twice-daily administration of Ritalin, but with less fluctuation.

Ritalin LA provides the same rapid onset as Ritalin and its efficacy lasts throughout the school day. Ritalin LA may be swallowed as whole capsules, or, for children who have difficulty swallowing, it may be administered by sprinkling the beaded contents on applesauce.

A double-blind, placebo-controlled study involving 134 patients, aged 6 to 12 years, demonstrated Ritalin LA to be effective in treating ADHD symptoms.

Ritalin LA is contraindicated in patients known to be hypersensitive to the drug or to Ritalin, in patients with glaucoma, in patients with motor tics, and in patients with a family history or diagnosis of Tourette's syndrome. In addition, Ritalin LA is contraindicated during treatment with monoamine oxidase inhibitors and should not be taken until at least 14 days after discontinuation of a monoamine oxidase inhibitor. Ritalin LA should be given cautiously to patients with a history of drug dependence or alcoholism.

Posted: June 2002


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