It will be a while before Cephalon’s avowedly anti-jet-lag drug gets the nod from the U.S. Food and Drugs Administration (FDA). The pharma has been told by the FDA that it will require more time to review the supplemental new drug application (sNDA) submitted by the company for Nuvigil.
Cephalon is seeking to expand Nuvigil’s label as a treatment for “improving wakefulness in patients with excessive sleepiness associated with jet lag disorder due to eastbound travel.”
The FDA had initially granted priority review status to the candidate which means a decision would have been out by Dec 29, 2009. However, with the agency asking for additional review time, a decision is now expected by March 29, 2010.
Nuvigil (armodafinil) is a follow-on version of Provigil (modafinil) which contributed about 50% to revenues in 2008.
Cephalon received FDA approval for Nuvigil in June 2007 for the treatment of excessive sleepiness associated with obstructive sleep apnea/hypopnea syndrome (OSAHS), narcolepsy and shift work sleep disorder (SWSD).
In addition to the jet lag disorder indication, Cephalon is evaluating Nuvigil’s effectiveness for other indications like traumatic brain injury, restless leg syndrome, major depressive disorder, schizophrenia and fatigue associated with cancer
"We will continue to work closely with the FDA to assist them in completing their review of our application in a timely manner and do not anticipate any further delays beyond the March 29, 2010, action date," said Dr. Lesley Russell, Chief Medical Officer at Cephalon. "We remain excited about this opportunity as there are no medications approved by the FDA to treat excessive sleepiness associated with eastbound jet lag disorder."
