Cephalon Inc. said Thursday that it is starting Phase IIItrials of the narcolepsy drug modafinil, which already isapproved in France for that indication and idiopathichypersomnolence.Cephalon, of West Chester, Pa., licensed exclusive rights todevelop and market the drug in the U.S. and Mexico inJanuary 1993 from Laboratoire L. Lafon of Paris. Cephalonlater acquired exclusive rights to the UK and Ireland aswell."Modafinil would be the first new treatment option for U.S.patients with narcolepsy in more than 30 years," said FrankBaldino, president and CEO of Cephalon. The disease ischaracterized by uncontrollable propensity to fall asleepduring the day.Cephalon said more than 125,000 Americans suffer fromnarcolepsy. Amphetamine-type stimulants can treat thesymptoms, but often are addictive and may have other sideeffects.Baldino told BioWorld that Cephalon hopes to demonstratethree advantages of modafinil over existing therapies in thePhase III trials. It wouldn't be a Schedule II drug, or have ahigh tendency toward abuse; patients wouldn't develop atolerance for modafinil; and modafinil would have a betterside effect profile. He said testing on 4,000 patients inFrance support the drug's advantages.One of the Phase III trials will study two doses of the drugagainst placebo; another will involve multiple doses andplacebo. Baldino said the trials are expected to enroll 700patients, who will be dosed every day for nine weeks.Endpoints in the study include quantitative sleep measures,including sleep lab testing and mean waking time, todetermine the degree of wakefulness. And there will bemeasures on the clinical global impression scale.Baldino said modafinil has a very specific effect on thealpha-adrenergic system. "The exact mechanism beyondthat is unknown, but it seems to enhance the couplingbetween the alpha receptor and the G protein."Cephalon hopes to file a new drug application (NDA) formodafinil in 1995, Baldino said, and also to file an NDA in1995 for its amyotrophic lateral sclerosis drug, Myotrophin,a recombinant human insulin-like growth factor.If approved, both drugs could be offered to neurologists,whom Cephalon will get to know through a deal withBristol-Myers Squibb Co. announced earlier this week.Cephalon will co-promote Bristol-Myers' Stadol NS nasalspray to neurologists in exchange for a 50-50 split of sales.Cephalon (NASDAQ:CEPH) stock was up 38 centsThursday, closing at $10 per share. n

-- Jim Shrine

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