Company on Target to File Supplemental New Drug Application in the Fourth
Quarter
FRAZER, Pa., Aug. 16 /PRNewswire-FirstCall/ -- Cephalon, Inc. (Nasdaq:
CEPH) today announced positive results from a 12-week, Phase 3 clinical
trial of FENTORA(R) (fentanyl buccal tablet) [C-II] in patients with
breakthrough pain associated with a broad range of chronic non-cancer pain
conditions. The study achieved statistical significance on the primary
endpoint. Results across the 12 weeks of treatment showed both
statistically significant and clinically relevant outcomes for patients
with breakthrough pain who were already receiving and who were tolerant to
opioid therapy for their underlying persistent pain. FENTORA is approved
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.
"We are excited to complete our Phase 3 program with this third and
final controlled study. These data show similar positive outcomes as those
with FENTORA in treating breakthrough pain in opioid-tolerant patients with
cancer, chronic neuropathic pain, and chronic low-back pain," said Dr.
Lesley Russell, Executive Vice President, Worldwide Medical and Regulatory
Operations. "We plan to submit these data to the Food and Drug
Administration in the fourth quarter as part of our supplemental New Drug
Application."
About the Study
The double-blind, placebo-controlled, variable dose Phase 3 trial
included 148 patients. The primary endpoint was the Sum of Pain Intensity
Differences from five to 60 minutes (SPID(60)) as assessed after 12 weeks
of treatment. SPID(60) is a measure that assesses analgesic efficacy of a
pain medication over the first 60 minutes after treatment. Patients treated
with FENTORA showed a statistically significant improvement on the primary
endpoint (p<0.0001) compared with placebo. FENTORA was generally well
tolerated by the study participants with side effects consistent with those
in the currently approved label. The company plans to present the data at a
major medical meeting in the future.
About Breakthrough Pain
Breakthrough pain is a component of chronic pain that is characterized
by its rapid onset, moderate to severe intensity, and relatively short
duration. Breakthrough pain has an average onset of three to five minutes
and typically lasts 30 to 60 minutes.
About FENTORA
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, as described below in the FENTORA label, for their
underlying persistent cancer pain. FENTORA incorporates a drug delivery
system that generates transient changes in pH, which may optimize how well
the tablet dissolves and how quickly the medicine passes across the lining
of the cheek, or buccal mucosa. 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. The
most common (greater than or equal to 10 percent) adverse events observed
in FENTORA cancer clinical trials were nausea, dizziness, vomiting,
fatigue, headache, constipation, anemia, somnolence, and peripheral edema.
Most adverse events were mild to moderate in severity. No attempt was made
to correct for concomitant use of around-the-clock opioids or
cancer-related symptoms. In addition, application site reactions were
reported in nine percent of patients, tended to occur early on treatment,
and resulted in treatment discontinuation in only two percent of patients.
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.
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 has delivered a seven-year compound annual
growth rate (CAGR) through 2006 greater than 75 percent 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, 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 the
timing of an sNDA filing for FENTORA; manufacturing development and
capabilities; market prospects for its products; sales, adjusted net income
and basic adjusted income per common share guidance for the third quarter
and full-year 2007; 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, +1-610-738-6198,
sbeckhar@cephalon.com, or Candace Steele, +1-610-727-6231,
csteele@cephalon.com; Investors, Chip Merritt, +1-610-738-6376,
cmerritt@cephalon.com, all of Cephalon, Inc.
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