Indication Sought for Breakthrough Pain Associated with Chronic Pain
Conditions in Patients Who are Already Taking Opioid Medications
Around-the-Clock
FRAZER, Pa., Nov. 12 /PRNewswire-FirstCall/ -- Cephalon, Inc. (Nasdaq:
CEPH) today announced it has submitted a supplemental New Drug Application
(sNDA) to the U.S. Food and Drug Administration (FDA) seeking approval to
market FENTORA(R) (fentanyl buccal tablet) [C-II] for the management of
breakthrough pain in opioid tolerant patients with chronic pain conditions.
Breakthrough pain is characterized by its rapid onset, moderate- to-severe
intensity, and relatively short duration. According to a study published in
the August 2006 issue of The Journal of Pain, up to 74 percent of patients
with non-cancer chronic pain conditions treated for persistent pain, such
as chronic low back and chronic neuropathic pain, will experience
breakthrough pain. Currently FENTORA is approved 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 pain.
"The clinical trials supporting this submission mark the first time a
pain medication has been evaluated as a treatment for breakthrough pain
associated with serious chronic pain conditions other than cancer," said
Dr. Lesley Russell, Executive Vice President, Worldwide Medical and
Regulatory Operations. "We look forward to working with FDA to broaden the
use of FENTORA to opioid tolerant patients with unresolved debilitating
breakthrough pain."
The FENTORA sNDA includes data from three randomized,
placebo-controlled clinical trials and one long-term open-label safety
study with a total of 941 opioid tolerant patients. The patients in the
FENTORA sNDA trials were treated for up to 18 months and had a broad range
of underlying chronic pain conditions, including chronic low back and
chronic neuropathic pain. In the randomized clinical trials, opioid
tolerant patients with chronic pain treated with FENTORA experienced
statistically significant improvements in relief from breakthrough pain
with an onset and duration of relief similar to that seen in studies of
FENTORA in patients with cancer pain. The FDA's typical review period for a
sNDA is 10 to 12 months.
"Breakthrough pain appears to be highly prevalent in some populations
with chronic non-cancer pain, and the commitment to use an opioid to manage
chronic pain should be accompanied by an effort to assess and manage the
breakthrough pain as well," said Dr. Russell Portenoy, Chairman, Department
of Pain Medicine and Palliative Care, Beth Israel Medical Center, in New
York City, and a principal investigator in the FENTORA clinical trials.
"New treatment options that specifically target breakthrough pain are
welcome, and are likely to improve the clinician's ability to address this
problem effectively."
About Breakthrough Pain
Millions of Americans suffer from chronic pain, a condition that often
consists of two distinct components: persistent pain, which is pain that is
continuous throughout the day, and breakthrough pain, which is a transitory
flare of moderate-to-severe pain in patients with otherwise managed
persistent pain. Breakthrough pain can reach peak intensity in as little as
three minutes and typically lasts for 30 to 60 minutes. It may occur during
a specific activity, spontaneously with no apparent cause, or when the dose
of the persistent pain medicine wears off.
About FENTORA
Approved in September 2006, FENTORA is the first tablet formulation of
the opioid fentanyl and the first new medication approved for the
management of breakthrough pain in opioid tolerant patients with cancer
since 1998. Its proprietary OraVescent(R) drug delivery system was
developed by Cephalon subsidiary CIMA LABS. FENTORA is covered by patents
until 2019.
The sugar-free FENTORA tablet is placed between the cheek and gum above
a rear molar tooth where it remains until it dissolves. When it comes into
contact with saliva, FENTORA's delivery system generates a chemical
reaction believed to optimize how well the tablet dissolves and how quickly
the medicine passes across the lining of the upper check, or buccal mucosa.
With FENTORA's drug delivery technology, approximately half of the medicine
is absorbed directly across the lining of the upper cheek and into the
bloodstream. Conventional short-acting oral opioids, often used to treat
breakthrough pain, are swallowed and must first be absorbed in the
gastrointestinal tract, which can take up to 30-45 minutes to reach effect.
In clinical trials, FENTORA was generally well tolerated. Most adverse
events occurring with FENTORA are typical opioid side effects. The most
serious adverse events associated with all opioids are respiratory
depression (potentially leading to apnea or respiratory arrest),
circulatory depression, hypotension, and shock. All patients should be
followed for symptoms of respiratory depression. Opioid side effects should
be expected and managed accordingly. The most common (greater or equal to
10 percent) adverse events observed in clinical trials of FENTORA in
patients with cancer were nausea, vomiting, application site abnormalities,
fatigue, anemia, dizziness, constipation, edema, asthenia, dehydration, and
headache. In clinical trials in patients with other chronic pain
conditions, the most common (greater or equal to 10 percent) adverse events
were nausea, vomiting, back pain, dizziness, headache, and somnolence.
Application site adverse events were reported in 12 percent of patients.
Most side effects were mild to moderate in severity. No attempt was made to
correct for concomitant use of around- the-clock opioids or cancer-related
symptoms.
Post-marketing reports of serious adverse events, including deaths in
patients treated with FENTORA, have been reported. Deaths occurred as a
result of improper patient selection and/or improper dosing. FENTORA is
contraindicated in the management of acute or postoperative pain including
headache/migraine. Life-threatening respiratory depression could occur at
any dose in patients not regularly taking around-the-clock opioids. The
label for FENTORA is currently being updated to reflect these and other
important safety considerations.
PHYSICIANS AND OTHER HEALTHCARE PROVIDERS MUST BECOME FAMILIAR WITH THE
IMPORTANT WARNINGS IN THIS LABEL.
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 only 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 nontolerant 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 Caregivers 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. Adjust doses as appropriate.
(See DOSAGE AND ADMINISTRATION.)
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.
The concomitant use of FENTORA with strong and moderate cytochrome P450
3A4 inhibitors may result in an increase in fentanyl plasma concentrations,
and may cause potentially fatal respiratory depression.
Full prescribing information about FENTORA, including boxed warning, is
available from http://www.FENTORA.com.
About Cephalon, Inc.
Cephalon, Inc. is an international biopharmaceutical company, recently
inducted into the World Economic Forum Community of Global Growth
Companies. For 20 years, the company has been dedicated to the discovery,
development and commercialization of innovative products in four core
therapeutic areas: central nervous system, pain, oncology and addiction.
Cephalon has delivered a seven-year compound annual growth rate (CAGR)
through 2006 greater than 75% and 2006 revenue of $1.760 billion. A member
of the Fortune 1000, 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's proprietary products in the United States include:
PROVIGIL(R) (modafinil) Tablets [C-IV], FENTORA, TRISENOX(R) (arsenic
trioxide) injection, AMRIX(TM) (cyclobenzaprine hydrochloride
extended-release capsules), VIVITROL(R) (naltrexone for extended-release
injectable suspension), GABITRIL(R) (tiagabine hydrochloride), NUVIGIL(TM)
(armodafinil) Tablets [C-IV] and ACTIQ(R) (oral transmucosal fentanyl
citrate) [C-II]. The company also markets numerous products
internationally. Full prescribing information on its U.S. products is
available at http://www.cephalon.com 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; interpretation of clinical results including the FENTORA clinical
trials discussed herein; prospects for regulatory approval, including
approval of the FENTORA sNDA and the timing of the FDA's review period for
this submission; manufacturing development and capabilities; market
prospects for its products; 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.
SOURCE Cephalon, Inc.
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Related links:
http://www.cephalon.com
http://www.prnewswire.com/comp/134563.html/
CONTACT:
Media: Stacey Beckhardt, +1-610-738-6198,
sbeckhar@cephalon.com, or Candace Steele, +1-610-727-6231,
csteele@cephalon.com, or Investors: Robert (Chip) Merritt,
+1-610-738-6376, cmerritt@cephalon.com, all of Cephalon, Inc.
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