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Cerimon Pharmaceuticals Initiates Phase II/III Clinical Studies To Evaluate Its Diclofenac Patch For Mild To Moderate Pain
Cerimon
Pharmaceuticals, Inc., announced it has initiated two randomized,
double-blind, placebo-controlled Phase II/III clinical studies of its once-
daily topical diclofenac sodium patch to treat mild to moderate pain. One
of the studies, designated the "SUPPORT" (Stop Underlying Pain with a
diclofenac Patch and Obtain Relief Topically) study, will assess the
efficacy and safety of Cerimon's patch compared to placebo for the
treatment of pain due to acute mild to moderate ankle sprains. The second
study, designated the "ACTIVE" (A Clinical Trial to Investigate the
effectiVEness of diclofenac pain patch) study, will assess the safety and
efficacy of Cerimon's patch compared to placebo for the treatment of pain
due to mild to moderate tendonitis or bursitis of the shoulder, elbow, or
wrist. Each study will enroll over 300 subjects, with 50 percent of the
subjects randomized to receive the diclofenac sodium patch and the other
half to receive placebo.
Paul J. Sekhri, President and CEO of Cerimon Pharmaceuticals, stated,
"Our diclofenac patch is designed to offer convenient, site-specific pain
relief to patients with mild to moderate forms of musculoskeletal pain
without systemic side effects associated with currently available oral
NSAIDs. Consumers in Japan and several other countries have responded
strongly to the advantages of topical diclofenac patches virtually
identical to our patch, and we believe this provides an indication of the
potential market demand in the U.S. Cerimon is moving its program forward
aggressively to address this unmet medical need, allowing us to build a
leadership position in the US pain market."
This is the second late-stage development program Cerimon commenced in
the past year. In April 2007, the Company initiated a Phase IIb study of
Simulect(R) (basiliximab) for moderate-to-severe steroid-refractory
ulcerative colitis.
Pain Market
Musculoskeletal pain is pain that affects the muscles, ligaments, and
tendons. Acute musculoskeletal injuries are common and can occur during
sports activities, exercise, or other physical activities. Acute
musculoskeletal injuries generally require rapid treatment, which often
includes the administration of anti-inflammatory drugs. Optimal topical
treatment should relieve acute pain and reduce swelling in the injured area
to restore normal movement. In addition, it should be safe and easy to
administer.
Pain represents a large and dynamic market in the United States. Oral
formulations of NSAIDs currently are marketed worldwide for the treatment
of inflammation and pain, including pain due to musculoskeletal injuries,
signs and symptoms of osteoarthritis and rheumatoid arthritis, menstrual
cramps, headache and other minor aches and pains. While traditional oral
NSAIDs are effective, they can cause serious gastrointestinal and other
adverse events. Further, the withdrawal of some COX-2 inhibitors has
removed a major therapeutic option for patients with multiple moderate and
severe forms of pain, resulting in a significant market opportunity. These
developments have created a significant need for a localized pain product
with a strong safety profile.
About Cerimon Pharmaceuticals
Cerimon Pharmaceuticals, Inc., is a biopharmaceutical company dedicated
to developing and commercializing therapeutic products for autoimmune
diseases, inflammation and pain. Cerimon believes these new treatment
options will enable physicians specialized in treating these conditions to
further improve the lives of their patients.
Cerimon currently has two drugs in development. Simulect(R)
(basiliximab) entered a Phase IIb study for moderate-to-severe
steroid-refractory ulcerative colitis in April 2007. In addition, the
Company has now initiated two Phase II/III studies of a topical patch
formulation of diclofenac sodium in patients with acute musculoskeletal
pain.
Cerimon is well financed, having closed a $70 million Series A
financing in late 2005 with the premier investors MPM, Nomura Phase4
Ventures, and OrbiMed Advisors.
For more information on Cerimon, please visit the Company's website at
http://www.cerimon.com.
Cerimon Pharmaceuticals, Inc.
http://www.cerimon.com
View drug information on Simulect.
Cerimon Pharmaceuticals iniþiazã de fazã II / III Studii clinice pentru a evalua sa Diclofenac Patch Pentru uºoarã pânã la moderatã Pain - Cerimon Pharmaceuticals Initiates Phase II/III Clinical Studies To Evaluate Its Diclofenac Patch For Mild To Moderate Pain - articole medicale engleza - startsanatate