Cephalon, Inc. (Nasdaq: CEPH) today announced that data from a Phase 3 clinical trial of
FENTORA(TM) (fentanyl buccal tablet) [C-II] demonstrate efficacy in the
management of breakthrough pain in opioid-tolerant patients with chronic
low back pain.
In the double-blind, placebo-controlled study, statistically
significant differences in pain intensity were apparent within 10 minutes
(p
Breakthrough Pain
Breakthrough pain - a component of chronic pain - is a transitory flare
of moderate-to-severe pain in patients with otherwise stable persistent
pain. Breakthrough pain can reach peak intensity in as little as three
minutes and typically lasts for 30 to 60 minutes. An estimated 64 percent
of all cancer patients treated for persistent pain - and an estimated 74
percent of patients treated for persistent pain from other chronic pain
conditions - will experience breakthrough pain.
IMPORTANT WARNINGS AND SAFETY INFORMATION
FENTORA contains fentanyl, an opioid agonist and a Schedule II
controlled substance, with an abuse liability similar to other opioid
analgesics. FENTORA can be abused in a manner similar to other opioid
agonists, legal or illicit. This should be considered when prescribing or
dispensing FENTORA in situations where the physician or pharmacist is
concerned about an increased risk of misuse, abuse or diversion. Schedule
II opioid substances which include morphine, oxycodone, hydromorphone,
oxymorphone, and methadone have the highest potential for abuse and risk of
fatal overdose due to respiratory depression.
FENTORA is indicated for the management of breakthrough pain in
patients with cancer who are already receiving and who are tolerant to
opioid therapy for their underlying persistent cancer pain. Patients
considered opioid tolerant are those who are taking at least 60 mg of oral
morphine/day, at least 25 mcg of transdermal fentanyl/hour, at least 30 mg
of oxycodone daily, at least 8 mg of oral hydromorphone daily or an
equianalgesic dose of another opioid for a week or longer.
Because life-threatening respiratory depression could occur at any dose
in opioid non-tolerant patients, FENTORA is contraindicated in the
management of acute or postoperative pain. This product is not indicated
for use in opioid non-tolerant patients.
Patients and their caregivers must be instructed that FENTORA contains
a medicine in an amount which can be fatal to a child. Patients and their
caregivers must be instructed to keep all tablets out of the reach of
children (see Information for Patients and Their Caregivers contained
within the prescribing information for disposal instructions).
Due to the higher bioavailability of fentanyl in FENTORA, when
converting patients from other oral fentanyl products, including oral
transmucosal fentanyl citrate (OTFC and Actiq(R)), to FENTORA, do not
substitute FENTORA on a mcg per mcg basis and adjust doses as appropriate
(see DOSAGE AND ADMINISTRATION contained within the prescribing
information).
FENTORA is intended to be used only in the care of opioid tolerant
cancer patients and only by healthcare professionals who are knowledgeable
of and skilled in the use of Schedule II opioids to treat cancer pain.What are Opioids?
For more information on what opioids are, and opioid-induced constipation (OIC), please see:
All About Opioids and Opioid-Induced Constipation (OIC)
Cephalon, Inc.
Founded in 1987, Cephalon, Inc. is an international biopharmaceutical
company dedicated to the discovery, development and marketing of innovative
products in four core therapeutic areas: central nervous system, pain,
oncology and addiction. Cephalon currently employs approximately 3,000
people in the United States and Europe. U.S. sites include the company's
headquarters in Frazer, Pennsylvania, and offices, laboratories or
manufacturing facilities in West Chester, Pennsylvania, Salt Lake City,
Utah, and suburban Minneapolis, Minnesota. Cephalon's European headquarters
are located in Maisons-Alfort, France.
The company currently markets six proprietary products in the United
States: PROVIGIL(R) (modafinil) Tablets [C-IV], FENTORA, TRISENOX(R)
(arsenic trioxide) injection, VIVITROL(R) (naltrexone for extended-release
injectable suspension), GABITRIL(R) (tiagabine hydrochloride), ACTIQ(R)
(oral transmucosal fentanyl citrate) [C-II], and numerous products
internationally. Full prescribing information on its U.S. products is
available at cephalon or by calling 1-800-896-5855.
In addition to historical facts or statements of current condition,
this press release may contain forward-looking statements. Forward-looking
statements provide Cephalon's current expectations or forecasts of future
events. These may include statements regarding anticipated scientific
progress on its research programs; development of potential pharmaceutical
products, including any future indications for FENTORA; interpretation of
clinical results, including the results of the clinical trials of FENTORA
in patients with chronic low back pain; prospects for regulatory approval;
market prospects for its product; sales and earnings guidance; and other
statements regarding matters that are not historical facts. You may
identify some of these forward-looking statements by the use of words in
the statements such as "anticipate," "estimate," "expect," "project,"
"intend," "plan," "believe" or other words and terms of similar meaning.
Cephalon's performance and financial results could differ materially from
those reflected in these forward-looking statements due to general
financial, economic, regulatory and political conditions affecting the
biotechnology and pharmaceutical industries as well as more specific risks
and uncertainties facing Cephalon such as those set forth in its reports on
Form 8-K, 10-Q and 10-K filed with the U.S. Securities and Exchange
Commission. Given these risks and uncertainties, any or all of these
forward-looking statements may prove to be incorrect. Therefore, you should
not rely on any such factors or forward-looking statements. Furthermore,
Cephalon does not intend to update publicly any forward-looking statement,
except as required by law. The Private Securities Litigation Reform Act of
1995 permits this discussion.
Cephalon, Inc
FENTORA
View drug information on Naltrexone Hydrochloride Tablets; Oxycodone and Aspirin.
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