Cephalon, Inc. Porter Novelli
Scott Melville (media) 610-738-6270 Mara Goldfarb (media) 212-601-8342
Sandra Menta (investors) 610-738-6376 Burns McClellan
Lisa Burns (investors) 212-213-4281
FOR IMMEDIATE RELEASE
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CEPHALON RECEIVES FDA APPROVAL OF PROVIGIL(R) (MODAFINIL) TABLETS [C-IV],
A NOVEL, WAKEFULNESS-PROMOTING TREATMENT FOR
EXCESSIVE DAYTIME SLEEPINESS ASSOCIATED WITH NARCOLEPSY
CEPHALON'S FIRST U.S. APPROVAL IS MILESTONE FOR COMPANY
West Chester, PA December 28, 1998 Cephalon, Inc. (NASDAQ: CEPH) today
announced that it has received approval from the U.S. Food and Drug
Administration (FDA) to market PROVIGIL(R) (modafinil) Tablets, a new, non-
amphetamine drug to improve wakefulness in patients with excessive daytime
sleepiness (EDS) associated with narcolepsy. PROVIGIL is a first-line treatment
that is well-tolerated.
"PROVIGIL is a significant advance in sleep medicine and exemplifies Cephalon's
commitment to addressing unmet medical needs with innovative therapies," said
Frank Baldino, Jr., Ph.D., President and Chief Executive Officer of Cephalon,
Inc. "Because PROVIGIL is our first product to receive marketing approval in
the United States, and is the first new non-amphetamine wakefulness-promoting
drug indicated to treat the excessive daytime sleepiness associated with
narcolepsy in 40 years, today's announcement marks a milestone for Cephalon and
for the narcolepsy community. We are pleased to have worked collaboratively and
productively with the FDA to complete the review of our marketing application in
a timely manner."
PROVIGIL will be available by prescription shortly after final scheduling is
announced by the U.S. Drug Enforcement Administration (DEA). The DEA has
proposed that PROVIGIL be placed into Schedule IV of the Controlled Substances
Act. The company's sales force, established in 1994, will market the product to
sleep centers, sleep specialists, and neurologists.
Narcolepsy is a chronic, lifelong neurological sleep disorder of unknown origin
afflicting an estimated 125,000 Americans. Narcolepsy can strike people of both
sexes and all races, with symptoms most commonly appearing in a person's teens
and early twenties. The most common and disabling symptom is EDS, which is
characterized by daytime sleep attacks and persistent drowsiness.
"Narcolepsy is a tremendously debilitating sleep disorder that impacts patients
and their families in countless ways," said William C. Dement, M.D., Ph.D.,
director of the Sleep Disorders Clinic and
Research Center at Stanford University. "PROVIGIL offers physicians an important
new therapy to improve wakefulness in patients with EDS associated with
narcolepsy."
Clinical trials involving more than 550 patients found PROVIGIL to be
efficacious in improving daytime wakefulness. Patients demonstrated overall
clinical improvement in the severity of their disease symptoms. PROVIGIL has
been found to be generally well-tolerated, with a low incidence of adverse
events relative to placebo. In controlled clinical trials, most adverse events
were mild to moderate. The most commonly observed were headache, infection,
nausea, nervousness, anxiety, and insomnia. No specific symptoms of withdrawal
were observed after discontinuation of PROVIGIL therapy.
"We've been anxiously awaiting the approval of PROVIGIL," said Merrill M.
Mitler, Ph.D., professor at The Scripps Research Institute in La Jolla, Calif.,
and a PROVIGIL clinical trial investigator. "There has been a real need for an
effective EDS treatment that is well-tolerated."
PROVIGIL EFFICACY
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The efficacy of PROVIGIL was established in two Phase 3, double-blind, placebo-
controlled, nine-week multicenter studies that were conducted with more than 550
patients who met the American Sleep Disorders Association criteria for
narcolepsy. Subjects in both studies were randomized to a daily dose of PROVIGIL
200 mg, PROVIGIL 400 mg, or placebo.
Both studies demonstrated improvement in objective and subjective measures of
excess daytime sleepiness for both the 200 mg and 400 mg doses compared to
placebo. Subjects treated with PROVIGIL experienced a statistically significant
greater ability to remain awake as measured by the Maintenance of Wakefulness
Test (MWT), an objective test of a person's ability to stay awake over time, and
a statistically significant improvement in disease symptom severity as measured
by the Clinical Global Impression of Change (CGI-C) Scale, an independent
researcher's assessment of changes in the severity of a patient's illness from
the time of study entry.
Patients taking PROVIGIL also experienced statistically significant treatment-
related improvements on other standardized measures, including a decrease in the
propensity to fall asleep as measured by the Multiple Sleep Latency Test (MSLT),
an objective test in which subjects are asked to try to fall asleep and time to
sleep onset is measured. In addition, patients experienced a decreased level of
daytime sleepiness as measured by the Epworth Sleepiness Scale (ESS), a
subjective measure in which patients are asked to rate their likelihood of
falling asleep during normal daily activities. Nighttime sleep measured with
nocturnal polysomnography was not affected by PROVIGIL.
The FDA approved dosing is 200 mg once daily. Once-daily dosing will simplify
treatment for patients.
PROVIGIL SAFETY AND TOLERABILITY
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PROVIGIL has been evaluated for safety in more than 2,200 subjects. In
controlled clinical trials, most adverse events were mild to moderate in
severity. Only five percent of patients taking PROVIGIL discontinued therapy
due to an adverse event. The most commonly observed adverse events associated
with the use of PROVIGIL more frequently than placebo-treated patients in
controlled U.S. and foreign studies were headache, infection, nausea,
nervousness, anxiety, and insomnia. There were no clinically meaningful
differences in vital signs, body weight or ECG recordings among treatment
groups.
PROVIGIL is contraindicated in patients with known hypersensitivity to
modafinil.
It is recommended that PROVIGIL not be used in patients with a history of left
ventricular hypertrophy or ischemic ECG changes, chest pain, arrhythmia or other
clinically significant manifestations of mitral valve prolapse in association
with central nervous system stimulant use.
Full prescribing information about PROVIGIL is available from Cephalon
Professional Services (1-800-896-5855). Consumers can also obtain more
information about excessive daytime sleepiness and narcolepsy by calling 1-888-
41-AWAKE.
Cephalon, Inc., headquartered in West Chester, PA, is an international
biopharmaceutical
company dedicated to the discovery, development and marketing of products to
treat
neurological disorders and cancer.
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