Cephalon Inc. has started enrolling patients in its U.S. clinical trials ofmodafinil for treating the sleep disorder narcolepsy, the WestChester, Pa., company announced Tuesday.
Cephalon filed the investigational new drug (IND) application forthese dose-ranging studies with the FDA in early July. The studies,which are intended to establish the drug's maximum tolerated dose,will be conducted in healthy volunteers to supply supporting data forpivotal Phase III efficacy trials.
Modafinil, which is a synthetic compound that acts selectively on thealpha adrenergic system in the brain, has been shown in Europeanclinical trials on more than 1,000 patients to reduce the daytimesleep attacks and drowsiness common to narcoleptics.
Cephalon (NASDAQ:CEPH) licensed modafinil from the drug'sdeveloper, Laboratoire L. Lafon, in January. At that time, Cephalonhad the rights to develop the drug in the U.S. and Mexico. Under arecent amendment to that agreement, signed late last week, Cephalonnow has the exclusive rights to market modafinil in the UnitedKingdom and Ireland as well.
Laboratoire L. Lafon of Paris received regulatory approval formodafinil in France in 1992 and expects to seek approval to sell thedrug in other European countries this year.
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