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news.The US Food and Drug Administration (FDA) has issued a second complete response letter (CRL) to Cephalon for its supplemental new drug application (sNDA) for Nuvigil (armodafinil) tablets [C-IV]as a treatment for excessive sleepiness associated with jet lag disorder resulting from eastbound travel.
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Nuvigil is indicated to improve wakefulness in patients with excessive sleepiness associated with treated obstructive sleep apnea (OSA), shift work disorder (SWD), or narcolepsy.
In its letter to the company, the FDA reiterated its previously stated concerns regarding the NUVIGIL sNDA.
Cephalon chief medical officer Lesley Russell said that Cephalon believes they met the agreed upon safety and efficacy endpoints in the Nuvigil sNDA clinical study conducted under a Special Protocol Assessment.
"However, following several conversations with the agency, and given this second complete response letter, the company believes that further communications with the FDA will not result in an approval of this application," Russell said.