Since the launch of Nuvigil on June 1, 2009, Cephalon has been aiming at approvals for additional indications, including people with jet lag and traumatic brain injury, as well as adjunctive therapy for schizophrenia and bipolar disorder, and fatigue associated with cancer treatment. "We expect NUVIGIL to be a much bigger drug than PROVIGIL ever was in a long run," CEO, Baldino, said in a February 11, 2010 Earnings Call.
However, in March 2010, the FDA nixed approval for jet lag, which Cephalon was counting on because it would have allowed sales reps to hit virtually every kind of physician that might treat jet lag, instead of only doctors who treat sleep disorders, according to market analysts.
In the last week of June, Cephalon filed a formal response to the FDA's non-approval. The FDA "classified the response as a class two resubmission requiring a six-month review with a PDUFA date of December 30," Baldino said in a July 27, Earnings Call.
Also, in June 2010, the results for a study of Nuvigil, in conjunction with antipsychotics, for schizophrenia showed the drug failed to meet its primary endpoint, and in the July 27, Earnings Call, Dr Lesley Russell, Cephalon's Chief Medical Officer, said the company had "decided not to move forward with cancer related to fatigue for NUVIGIL."
Hammered Again in Court
On the same day that the FDA refused approval of Nuvigil for jet lag, a federal judge refused to dismiss the antitrust lawsuits filed against Cephalon by the Federal Trade Commission and others.
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