Cephalon issues Nuvigil labelling update

Cephalon has this week announced that the US Food and Drug Administration (FDA) will continue in its evaluation of an isolated case of serious rash experienced during a clinical trial of Sparlon (modafinil).

The FDA has asked for further information to better contextualise this incident in the safety profile for the compound that has had over a decade of commercial use. Nuvigil (armodafinil) is a single-isomer formulation of modafinil.

No further information regarding Nuvigil tablets has been requested by the administration and it will work with Cephalon regarding the labelling of the product.

Dr Lesley Russell, executive vice president of worldwide medical and regulatory operations and Cephalon, said: “We are pleased that the agency continues to work with us and outside experts in trying to better understand this case in the context of modafinil’s generally benign side effect profile.”

She added that this was a vital chance to guarantee that the final labelling for Nuvigil properly reflects the medical condition of the affected child.

Last month, the US Patent and Trademark Office issued Cephalon with a patent for Nuvigil, one due to expire in December 2023.

The company stated that it believed polymorphic form I to be the most stable crystalline type of novel polymorph associated with armodafinil.