Cephalon Inc. said data from a second Phase III trial of modafinilshowed the drug was effective in combating narcolepsy, a disorderthat causes excessive drowsiness and uncontrolled periods of sleep.
The West Chester, Pa.-based company also released details of resultsfrom the first successful Phase III study, whose general findings werereported in February 1996.
Modafinil, whose brand name is Provigil, is a synthetic compoundCephalon licensed from Laboratoire L. Lafon, of Paris, whichmarkets the drug in France. Cephalon has rights to sell modafinil inthe U.S., U.K., Ireland, Mexico and Japan.
Although the drug's exact mechanism of action is not known, it isbelieved to affect alpha adrenergic receptors in the brain. Narcolepsyafflicts about 125,000 people in the U.S.
In both Phase III studies, modafinil achieved statistical significancein its primary endpoints, which were improving patients' wakefulnessand overall well-being.
Cephalon's stock (NASDAQ:CEPH) closed Thursday at $22, down50 cents.
Jason Rubin, the company's vice president of corporatecommunications, said a new drug application (NDA) for modafinilprobably will be submitted to the FDA in the second half of this year.
The second Phase III study involved 273 patients at 21 U.S. medicalcenters. Patients received one of two modafinil doses (200 mg or 400mg) or a placebo daily for nine weeks. Those treated with the drugstayed awake 50 percent longer than those receiving a placebo. Asfor their well-being, 60 percent of the patients in the higher dosegroup and 57 percent in the lower dose group improved comparedwith 37 percent in the placebo group.
The first Phase III trial enrolled 285 patients at 18 medical centers.Dosing and length of treatment were the same as in the second study.Compared with patients receiving a placebo, those in the high dosegroup stayed awake 76 percent longer while those in the low dosegroup stayed awake 61 percent longer.
More patients experienced improvement in their overall conditions inthe treated group during the first study. Sixty-five percent in the lowdose group and 72 percent in the high dose group improvedcompared with 37 percent in the placebo group.
Cephalon experienced a setback in January 1996 with its other majordrug candidate, Myotrophin for amyotrophic lateral sclerosis (LouGehrig's disease). After reporting two positive Phase III trials, theFDA expressed concern about one of the studies, resulting inCephalon's failure to get a treatment investigational new drug (IND)application for the recombinant human insulin-like growth factor.The treatment IND would have made Myotrophin widely availablepending action on an NDA, which Cephalon expected to file earlythis year.
Rubin said Thursday a meeting with the FDA to discuss Myotrophinhas not been scheduled and he could not estimate when the NDAwould be submitted. n
-- Charles Craig
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