Once-daily Ritalin close to FDA approval

NEW YORK, Oct 02 (Reuters Health) - A form of the attention-deficit/hyperactivity disorder drug Ritalin that can be taken once daily is close to being approved by the US Food and Drug Administration (FDA), the drug's makers Novartis Pharmaceuticals Corp. and Celgene Corp. announced Tuesday. The extended-release drug, called Ritalin LA, would eliminate the need to administer Ritalin during school, the companies said.

The drug's active ingredient, as in earlier versions of the medication, is the stimulant methylphenidate.

The companies received an approvable letter from the FDA, which usually precedes full FDA approval. The approvable letter is a mechanism the federal agency uses when it has questions that need to be resolved before marketing approval is granted for a particular drug.

A spokeswoman for Warren, New Jersey-based Celgene told Reuters Health that Ritalin LA was developed, as were the other Ritalin products, in order to give physicians greater flexibility in treating attention-deficit/hyperactivity disorder (ADHD). Since the drug is often used to treat children, she said, doctors are especially desirous of having the ability to treat patients all day, as well as for limited periods such as during school hours.

Although Ritalin LA employs a newer technology that allows for a rapid onset of action compared with Ritalin SR, which has been available since 1982, a spokeswoman from Novartis said that the company has no plans at this time to phase-out the earlier product.

Currently, there are two once-daily treatments for ADHD available in the US: Alza's Concerta and Celltech's Metadate, both of which have methylphenidate as their active ingredient.

Also, in August, Shire Pharmaceuticals received an approvable letter for its once-daily ADHD treatment Adderall (amphetamine/dextroamphetamine).