Cephalon Inc. released data from a Phase III trial of modafinilshowing the drug was successful in keeping awake people withnarcolepsy, which subjects sufferers to uncontrolled sleep attacks.

The study was one of two Phase III trials being conducted by theWest Chester, Pa.-based company to support a new drug application(NDA) for modafinil, whose brand name is Provigil.

The Phase III placebo-controlled trial data reported Monday involved285 narcolepsy patients at 18 medical centers in the U.S. Patients,divided into three groups, received one of two doses of modafinil or aplacebo every day for nine weeks.

Preliminary analysis of the data revealed the treatment achievedstatistical significance in its two primary endpoints: reducing daytimesleepiness and improving overall patient well-being.

Jason Rubin, Cephalon's vice president of corporatecommunications, told BioWorld Today details of the Phase III triallikely will be presented at an Association of Professional SleepSocieties (APSS) meeting in Washington at the end of May.

The second Phase III study, involving 273 patients, also is a nine-week placebo-controlled trial being conducted in the U.S. Rubin saiddata from that study also may be available for presentation at theAPSS conference.

Cephalon expects to file an NDA for modafinil by mid-1996, Rubinadded.

Narcolepsy affects about 125,000 people in the U.S. Patientsuncontrollably fall asleep when they want to stay awake andexperience interrupted sleep when they are trying to rest.

Current treatments involve amphetamine-type stimulants, which canbe addictive and have other side effects. The most frequent adversereaction associated with modafinil in the first Phase III study washeadache.

To evaluate the effects of modafinil, participants in the study weremonitored in sleep laboratories and their overall well-being wasmeasured by physicians using a standard scale called the ClinicalGlobal Impression of Change.

Modafinil is a synthetic compound whose exact mechanism of actionis not known. It is believed to affect alpha adrenergic receptors,which are in the brain and are involved in sleep.

Cephalon licensed modafinil in 1993 from Laboratoire L. Lafon, ofParis, which markets the drug in France. Cephalon acquired rights tosell modafinil in the U.S., U.K., Ireland, Mexico and Japan.

Cephalon's stock (NASDAQ:CEPH) closed Monday at $26.37, down37 cents.

The positive modafinil trial data did little to help Cephalon recoverfrom last month's setback at the FDA with Myotrophin foramyotrophic lateral sclerosis (ALS), which also is called LouGehrig's disease.

The FDA expressed concerns about data from one of the two PhaseIII trials in response to Cephalon's application for a treatmentinvestigational new drug (IND) application for Myotrophin, which isrecombinant human insulin-like growth factor.

News of the FDA concerns sent the company's stock plummetingJan. 19, 1996, $12.50 to $23.38, a 35 percent decline. The sharp dropcountered a 400 percent increase the last half of 1995 based on thetwo Phase III studies, both of which were described as positive.

A treatment IND would have made Myotrophin widely availablepending action on an NDA, which Cephalon expected to file earlythis year.

Rubin said a meeting with the FDA to discuss Myotrophin has not yetbeen scheduled. n

-- Charles Craig

(c) 1997 American Health Consultants. All rights reserved.