Cephalon Inc. announced Tuesday that it has filed aninvestigational new drug application (IND) for clinical trials ofmodafinil in narcolepsy.
"We filed this IND to allow us to perform the additional clinicalstudies required by the FDA to supplement the data packageused to obtain market approval for modafinil in France," saidFrank Baldino Jr., Cephalon's president and chief executiveofficer.
A Phase II trial in the U.S. will examine a broader dose range in48 patients, spokeswoman Lyn Hyduke said.
Modafinil received regulatory approval in France in February1992 for the treatment of narcolepsy. Cephalon (NASDAQ:CEPH)licensed modafinil from its developer, Laboratoire L. Lafon ofParis, receiving rights to develop, market and sell it in the U.S.and Mexico. Cephalon agreed to fund clinical development ofmodafinil in both countries.
"The modafinil program is advancing as anticipated," Baldinosaid, "and we are targeting the end of this year for theinitiation of Phase III clinical studies."
Earlier this year, the FDA granted orphan drug status formodafinil in the treatment of narcolepsy, a multigenic illnesscharacterized by uncontrollable daytime sleep attacks thataffects more than 125,000 people in the U.S.
Narcolepsy is normally treated with amphetamine-typestimulants, which can inhibit the symptoms but are oftenaddictive and may have other side effects, such as contributingto hypertension.
Modafinil is the first new product in 30 years for treating thedebilitating condition, Baldino said. Data from more than 1,000patients in Europe showed that it significantly reduced daytimesleep attacks and drowsiness and had no significant adverseside effects.
Unlike most stimulants, the compound apparently affectsalpha-adrenergic receptors, possibly through theneurotransmitter norepinephrine, Hyduke said. It was obtainedby the West Chester, Pa., company to enhance its focus onneurologic treatments.
(c) 1997 American Health Consultants. All rights reserved.