By Kim Coghill
Cephalon Inc. released positive data from a Phase III study that will be used as part of a supplemental new drug application for expanded use of Provigil, a wake-promoting agent initially approved in 1998.
The 327-patient study showed that Provigil (modafinil) helped keep people awake who were suffering from excessive daytime sleepiness (EDS) associated with obstructive sleep apnea. Patients with sleep apnea are awakened throughout the night when their airwaves become blocked.
Provigil is on the market for EDS resulting from narcolepsy, a chronic neurological disorder affecting between 100,000 and 125,000 Americans. The drug is a stimulant that appears to act selectively in the areas of the brain that regulate normal wakefulness rather than in a wide region of the brain, like amphetamines and other stimulants do.
Cephalon, of West Chester, Pa., late next year intends to seek approval of Provigil for any clinical disorder in which excessive sleepiness is a major symptom. The company plans to enter the market in early 2004 for those conditions.
¿The important impact of today¿s announcement is the support the study provides for the [new drug application] we intend to file next year,¿ Robert Grupp, Cephalon¿s vice president of corporate communications, told BioWorld Today. ¿We have talked to the FDA already about broadening Provigil¿s label and they have suggested we compile data on narcolepsy, sleep apnea and shift work.¿
Already the company has completed two studies each on narcolepsy and sleep apnea, and by the middle of next year, a second study on shift work will be complete.
The 327-patient study released Tuesday was a randomized, double-blind, placebo-controlled, parallel-group trial. Grupp said primary and secondary endpoints were achieved. ¿This new study is larger than others and it really reaffirms what we¿ve seen in other studies,¿ he said.
The primary endpoint measures were the Maintenance of Wakefulness Test (MWT), an objective test of wakefulness, and the Clinical Global Impression of Change (CGI-C), a subjective assessment. Meanwhile, the secondary endpoints were measured using the Epworth Sleepiness Scale, the Functional Outcome of Sleep Questionnaire and the SF36 Health Quality of Life Survey.
Statistically significant improvements in wakefulness and overall clinical condition were found at 12 weeks on the MWT (p<0.0001) and CGI-C (p<0.001) in patients treated with either Provigil dose compared to placebo.
About a year ago the company¿s stock dropped 40 percent to close at $38.75 when it disclosed poor results from a Phase II study of Provigil for the treatment of attention deficit hyperactivity disorder in adults. According to the study, Provigil was no more effective than placebo. (See BioWorld Today, Aug. 1, 2000.)
Grupp said Cephalon has abandoned further studies for that indication.
Cephalon¿s stock (NASDAQ:CEPH) closed Tuesday at $54.92, up 72 cents.