FDA Requests Enhancements to Risk Mitigation Strategies Consistent with
Company's Recommendations
FRAZER, Pa., Sept. 15 /PRNewswire-FirstCall/ -- Cephalon, Inc. (Nasdaq:
CEPH) announced today receipt of a complete response letter from the Food
and Drug Administration (FDA) for its supplemental New Drug Application
(sNDA) for FENTORA(R) (fentanyl buccal tablet) [C-II] as a treatment for
opioid-tolerant patients with non-cancer breakthrough pain. In its letter,
the FDA requested that Cephalon implement and demonstrate the effectiveness
of proposed enhancements to the current FENTORA risk management program.
These enhancements are consistent with the strategies the company presented
at the FDA Advisory Board meeting on May 6, 2008. The agency also requested
routine safety updates; no additional safety or efficacy studies were
requested. In accordance with new FDA regulations, the company anticipates
receiving a second communication from the agency requesting that the
FENTORA Risk Minimization Action Plan (RiskMAP) be converted to incorporate
the new standards for the Risk Evaluation and Mitigation Strategy (REMS)
safety plan.
"The FDA request for revisions to the FENTORA risk management program
was expected and over the last four months we have been working diligently
to prepare for implementation of the program as soon as possible. We
anticipate that the subsequent letter from the agency will provide useful
guidance to finalize the timeline for and implementation of ongoing
enhancements to the risk management program," said Dr. Lesley Russell,
Executive Vice President and Chief Medical Officer at Cephalon. "We intend
to put into place a REMS that we hope will not only demonstrate
effectiveness for mitigating the risks associated with FENTORA but also
pave the way for a new industry standard for opioid pain medications."
To address the FDA's request in the complete response letter, Cephalon
plans to implement COVERS(TM), a first-of-its-kind initiative designed to
minimize the potential risk of overdose from an opioid through appropriate
patient selection. This innovative component of the FENTORA REMS program
will educate and engage physicians, patients and pharmacists to assure that
patients prescribed FENTORA are opioid-tolerant. Additionally, the company
will continue to enhance its existing programs to mitigate risks associated
with abuse and misuse.
FENTORA is currently approved for the management of breakthrough pain
in opioid-tolerant patients with cancer (for full prescribing information,
visit http://www.fentora.com). The FENTORA sNDA, submitted by Cephalon in November
2007, is based on data from three randomized, placebo-controlled clinical
trials in patients with chronic non-cancer pain conditions and one
long-term open-label safety study with a total of 941 patients. The
patients in these 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 these 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.
Cephalon, Inc.
Founded in 1987, Cephalon, Inc. is an international biopharmaceutical
company dedicated to the discovery, development and commercialization of
innovative products in four core therapeutic areas: central nervous system,
pain, oncology and addiction. 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. The company's European headquarters are located in
Maisons-Alfort, France.
The company's proprietary products in the United States include:
TREANDA(R) (bendamustine hydrochloride) for Injection, AMRIX(R)
(cyclobenzaprine hydrochloride extended-release capsules), 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 results of the
FENTORA clinical trials; prospects for final regulatory approval of
FENTORA; manufacturing development and capabilities; market prospects for
its products, particularly with respect to FENTORA 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, +1-610-738-6198, or
cell, +1-610-247-0212, sbeckhar@cephalon.com, or Candace Steele,
+1-610-727-6231, or cell, +1-484-318-0804, csteele@cephalon.com,
or Investor Relations, Chip Merritt, +1-610-738-6376,
cmerritt@cephalon.com, all of Cephalon
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