Data Showed AMRIX is Superior to Placebo, Similar Efficacy to Immediate
Release Formulation Taken Three Times a Day, and Less Daytime Drowsiness
FRAZER, Pa., Feb. 14 /PRNewswire-FirstCall/ -- Cephalon, Inc. (Nasdaq:
CEPH) announced the pooled analysis of two pivotal randomized,
placebo-controlled clinical trials showing that AMRIX(R) (cyclobenzaprine
hydrochloride extended-release capsules), a new once-daily extended-release
skeletal muscle relaxant, was superior to placebo. AMRIX had similar
efficacy to cyclobenzaprine immediate-release (CIR) taken three times a day
in alleviating acute muscle spasm associated with lower back and neck pain.
In addition, less daytime drowsiness was observed with AMRIX compared to
CIR, although such a comparison was not pre-specified in the statistical
analysis plan. These results were presented today at the 24th Annual
Meeting of the American Academy of Pain Medicine in Orlando, FL.
"Typically, muscle relaxants are taken multiple times a day, which can
make it difficult for some of my patients with acute muscle spasm
associated with lower back and neck pain to adhere to their treatment
regimen," said Arnold J. Weil, MD, of Non-Surgical Orthopaedics in Atlanta,
GA, and the lead investigator in these studies. "With data supporting AMRIX
as an effective once-daily treatment, health care professionals now have an
easy-to-administer treatment option to offer their patients who are
suffering from acute muscle spasm."
The data, which were the basis for the U.S. Food and Drug
Administration approval of AMRIX, were pooled from two identical 14-day
randomized, double-blind, placebo-controlled, multicenter studies,
evaluating a total of 504 adults across four study arms (AMRIX 15 mg, AMRIX
30 mg, placebo, and CIR 10 mg three times daily). These participants had
moderate-to-severe muscle spasm of cervical or lumbar origin associated
with local pain, tenderness, limitation of motion, and restrictions of
daily living. In these studies, patients and physicians assessed how
helpful the medication was in the treatment of acute muscle spasm. Primary
endpoints of the clinical trials were Patient's Rating of Medication
Helpfulness at day four of treatment and Physician's Clinical Global
Assessment at day four.
Study results of the Patient's Rating of Medication Helpfulness, a
measure of efficacy, showed that a higher proportion of patients (p<0.025)
taking AMRIX 15 mg (56.0 percent; n=116) and AMRIX 30 mg (56.7 percent;
n=120) reported "good" to "excellent" responses compared with the placebo
group (40.0 percent; n=115) at day four. The distribution of responses for
AMRIX and CIR was similar. The trials did not demonstrate significant
differences among the study groups on the Physician's Clinical Global
Assessment at day four.
In a scale of Patient-Rated Daytime Drowsiness at day four, more
patients in the AMRIX groups (15 mg, 50.4 percent, and 30 mg, 42.1 percent)
had "no to very little" drowsiness compared with the CIR group (28.8
percent). As expected, more patients in the AMRIX groups had daytime
drowsiness compared with placebo.
The majority of all adverse events reported in these trials were mild
in intensity. The most common side effects of AMRIX (greater than or equal
to three percent) were dry mouth, dizziness, fatigue, nausea, and
constipation. Somnolence (a state of drowsiness) was the most common
adverse event leading to discontinuation (two patients in the AMRIX 30 mg
group and eight in the CIR group).
About AMRIX
AMRIX is indicated for short-term use (up to two or three weeks) for
relief of muscle spasm associated with acute, painful musculoskeletal
conditions. The first and only once-daily muscle relaxant, AMRIX is
available in 15 and 30 mg dosage strengths.
AMRIX is contraindicated with concomitant use of monoamine oxidase
(MAO) inhibitors or within 14 days after their discontinuation; in patients
during the acute recovery phase of myocardial infarction; in patients with
arrhythmias, heart block conduction disturbances, or congestive heart
failure; and in patients with hyperthyroidism. AMRIX may enhance the
effects of alcohol, barbiturates, and other CNS depressants. AMRIX should
not be used in elderly patients or in patients with impaired hepatic
function. AMRIX should be used with caution in patients with a history of
urinary retention, angle-closure glaucoma, increased intraocular pressure,
and in patients taking anticholinergic medication.
For complete product information, visit http://www.amrix.com.
About 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:
PROVIGIL(R) (modafinil) Tablets [C-IV], FENTORA(R) (fentanyl buccal tablet)
[C-II], TRISENOX(R) (arsenic trioxide) injection, AMRIX, 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, particularly with respect to
the AMRIX clinical trials; 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.amrix.com
http://www.prnewswire.com/comp/134563.html /
CONTACT:
Media, Stacey Beckhardt, +1-610-247-0212,
sbeckhar@cephalon.com; Krista Poplau, +1-215-238-8500,
kpoplau@voxmedica.com; Investors, Robert 'Chip' Merritt,
+1-610-738-6376, cmerritt@cephalon.com
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