Cephalon submits Sparlon side effect evidence to FDA

Cephalon has submitted evidence of side effects due to Sparlon (modafinil) to the US food and drug administration (FDA).

The pharmaceutical company was told to do so after concerns over Stevens-Johnson syndrome (SJS) in three children prevented approval last month.

New information about the serious skin condition and any link to Sparlon in one of the children has now been submitted to the drug regulators. Dr Paul Blake, executive vice-president at Cephalon, said: “We are very pleased that the FDA has decided to review this new information very carefully, and hope that it will provide a basis for the approval of Sparlon.”

Sparlon is designed to treat attention deficit hyperactivity disorder (ADHD) in children, but the FDA did not approve it over fears of a link to SJS, recommending instead that the company conduct a month-long trial of at least 3,000 patients.

With the new evidence in hand, Cephalon said it was confident that the case was not one of SJS, which is a serious skin rash condition.

Following the submission, Dr Blake added that he anticipates “further discussions with the FDA in the coming weeks”.

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