All Efficacy Measures Reached Statistical Significance
FRAZER, Pa., May 1 /PRNewswire-FirstCall/ -- A Cephalon, Inc. (Nasdaq:
CEPH) Phase 3 clinical trial presented today at the 59th Annual Meeting of
the American Academy of Neurology in Boston highlights data demonstrating
that FENTORA(R) (fentanyl buccal tablet) [C-II] is beneficial for the
treatment of breakthrough pain in patients with neuropathic pain who are
already taking opioids around-the clock to manage their persistent pain.
This study marks the first time an opioid has been evaluated in patients
with breakthrough pain associated with chronic neuropathic pain.
"This study provides strong evidence that opioids like FENTORA may be
useful in managing breakthrough pain in patients with chronic neuropathic
pain," said Dr. David Simpson, Professor of Neurology at Mount Sinai
Medical Center and primary author of this study. "With FENTORA, patients
experienced statistically significant and clinically meaningful
improvements in pain control and expressed a preference for this medication
over the opioid they had previously been prescribed to manage their
breakthrough pain."
Breakthrough pain -- a component of chronic pain -- is a flare of
moderate-to-severe pain that occurs in the context of controlled persistent
pain and is characterized by rapid onset, moderate-to-severe intensity, and
relatively short duration. An estimated 74 percent of patients with
controlled persistent pain from noncancer chronic pain conditions,
including neuropathic pain, will experience breakthrough pain with a median
onset of 10 minutes. In this patient population, breakthrough pain episodes
can typically last 60 minutes. FENTORA, which is approved for the
management of breakthrough pain in patients with cancer who are already
taking and who are tolerant to opioids for their underlying persistent
cancer pain, is designed to provide early-onset analgesia via a chemical
reaction that enhances fentanyl absorption across the inner lining of the
cheek. Cephalon is pursuing clinical development of FENTORA in breakthrough
pain associated with conditions other than cancer, including chronic
neuropathic pain, and expects to file a supplemental New Drug Application
this year. FENTORA is not approved for use in these conditions.
The multi-center study evaluated FENTORA in adult patients with chronic
neuropathic pain who were diagnosed with a variety of conditions including
diabetic peripheral neuropathy, traumatic injury, postherpetic neuralgia
and complex regional pain syndrome (CRPS) -- a chronic condition caused by
a nerve disorder that occurs at the site of injury, often a fractured arm
or leg. All patients were already receiving various around-the-clock opioid
medications for persistent pain, and short-acting opioids for their one to
four episodes of breakthrough pain a day.
The open label titration phase of the study enrolled 103 patients who
were individually titrated to a dose that provided adequate pain relief for
at least two of three breakthrough pain flares. Of these, 102 patients
received at least 1 dose of FENTORA and 80 patients (78 percent) identified
a successful dose with acceptable side effects. Only six patients (6
percent) withdrew from the study due to lack of efficacy. In the
randomized, placebo- controlled, double-blind treatment phase in which all
patients were exposed to both FENTORA and placebo, data from 75 patients
(95 percent of patients who reached a successful dose) were evaluable for
efficacy. Key study findings include:
-- The primary efficacy measure, the Sum of Pain Intensity Differences
from 5 though 60 minutes (SPID60), demonstrated significantly higher
scores compared to placebo (9.6 +/- 0.75 vs. 5.7 +/- 0.72, p<0.0001).
-- Reduction in pain intensity (PI) and pain relief (PR) was significantly
greater with FENTORA than placebo at 10 minutes (p<0.05, p=0.0005,
respectively) and maintained throughout the 120 minute evaluation
period (p<0.0001 for both PI and PR).
-- Significantly more episodes treated with FENTORA showed clinically
meaningful reductions in pain intensity (greater or equal to 33 percent
reduction at 10 minutes, p=0.008; greater or equal to 50 percent
improvement at 15 minutes, p=0.0057). These improvements persisted
throughout the 120 minute measurement period (p<0.0001).
-- The majority of patients preferred FENTORA over their previous
breakthrough pain treatment, rating it good or excellent with respect
to onset of action (72 percent), ease of administration (78 percent),
and convenience of use (79 percent).
-- FENTORA was generally well-tolerated. Adverse events associated with
FENTORA in the clinical trial were typical of those seen with opioids,
with the exception of mild and transitory application site
abnormalities (8 percent). The most common side effects included
nausea (13 percent), dizziness (13 percent), drowsiness (10 percent),
and vomiting (5 percent). Of the 102 patients included in the safety
evaluation, 12 withdrew from the study due to adverse events during the
titration phase; none were due to application site abnormalities.
There were no reports of respiratory depression or other serious
adverse events related to FENTORA in this study.
"This study shows the important role FENTORA can play in the management
of breakthrough pain in patients with neuropathic conditions who are
already receiving opioids for their persistent pain," said Dr. Lesley
Russell, Executive Vice President, Worldwide Medical and Regulatory
Operations. "There is a need to identify additional treatment strategies
for this patient population, and these data demonstrate that FENTORA may be
an option for breakthrough pain associated with chronic neuropathic 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.
Full prescribing information about FENTORA, including boxed warning, is
available from http://www.FENTORA.com or Cephalon Professional Services and
Medical Information (1-800-896-5855)
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's products in the United States include: 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]; numerous products are marketed
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, including any future indications for FENTORA; interpretation of
clinical results, including the results of the clinical trials of FENTORA
in patients with neuropathic 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.
SOURCE Cephalon, Inc.
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Related links:
http://www.cephalon.com
http://www.FENTORA.com
http://www.prnewswire.com/comp/134563.html /
CONTACT:
Media, Stacey Beckhardt of Cephalon, Inc.,
+1-610-738-6198, mobile, +1-610-247-0212, sbeckhar@cephalon.com;
or Catherine Collier for Cephalon, Inc., +1-212-886-2214,
ccollier@cooneywaters.com; or investors, Robert (Chip) Merritt of
Cephalon, Inc., +1-610-738-6376, officecmerritt@cephalon.com
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