Navigation Links
Cerimon Pharmaceuticals Initiates Phase II/III Clinical Studies to Evaluate its Diclofenac Patch for Mild to Moderate Pain
Date:1/16/2008

SOUTH SAN FRANCISCO, Calif., Jan. 16 /PRNewswire/ -- Cerimon Pharmaceuticals, Inc., announced today 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.


'/>"/>
SOURCE Cerimon Pharmaceuticals, Inc.
Copyright©2008 PR Newswire.
All rights reserved

Related medicine technology :

1. Cerimon Pharmaceuticals Initiates Phase I Clinical Study of Topical Diclofenac Sodium Patch
2. Morria Biopharmaceuticals Plc Announces Preliminary Safety and Tolerability Results From Its Phase I Clinical Study of MRX-4 in Allergic Rhinitis Patients
3. First Patient Enrolled in Cogentus Pharmaceuticals Pivotal Phase 3 Trial of Novel Combination Medicine
4. Arena Pharmaceuticals Announces Positive Phase 1a Clinical Trial Results of APD791 for the Treatment of Arterial Thrombosis and Initiates Phase 1b Clinical Trial
5. Vion Pharmaceuticals Announces FDA Lift of Clinical Hold on Phase III Study of Cloretazine(R) (VNP40101M) and Cytarabine in Relapsed AML
6. Arena Pharmaceuticals Announces APD668 Initial Clinical Study Results Suggest Glucose-Dependent Insulinotropic Receptors May Improve Glucose Control in Patients With Type 2 Diabetes
7. Fovea Pharmaceuticals Receives Orphan Drug Designation from EC for RdCVF for the Treatment of Retinitis Pigmentosa
8. VIA Pharmaceuticals Enrolls First Patient in Phase 2 Clinical Trial to Measure Impact of VIA-2291 to Reduce Vascular Inflammation
9. Jazz Pharmaceuticals, Inc. Announces Receipt of FDA Orphan Drug Designation for Recurrent Acute Repetitive Seizures Product Candidate
10. Idenix Pharmaceuticals Provides Update on Hepatitis C Pipeline at JP Morgan Healthcare Conference
11. Alseres Pharmaceuticals Concludes Enrollment in the Cethrin(R) Phase I/IIa Clinical Trial in Acute Spinal Cord Injury
Post Your Comments:
*Name:
*Comment:
*Email:
(Date:2/24/2017)... , Feb. 24, 2017 Juan ... & Associates PC , a boutique securities firm headquartered ... York City , announces that a class action ... Massachusetts  against Inotek Pharmaceuticals Corporation (NASDAQ: ... the Company,s securities between July 23, 2015 and December 30, ...
(Date:2/24/2017)... NEW YORK , Feb. 23, 2017 Report ... The report provides separate comprehensive analytics for the US, ... Europe , Asia-Pacific , ... estimates and forecasts are provided for the period 2015 through ... markets. Market data and analytics are derived from primary and ...
(Date:2/24/2017)... -- ITL Limited, ( ASX : ITD ), une société ... les excellents résultats semestriels clos le 31 décembre 2016 ... complète « Résultats et mise à jour sur la croissance ... Faits marquants ... en hausse de 104 %) Bénéfice par ...
Breaking Medicine Technology:
(Date:2/24/2017)... ... February 24, 2017 , ... ... which specializes in thought leadership , media relations, social media, content marketing ... that will be powered through Act-On, an intuitive marketing automation platform. , Rosica ...
(Date:2/23/2017)... ... February 23, 2017 , ... ... Justice jointly issued a letter to withdraw previous guidance issued by ... gender identity. The guidance issued in May 2016 by the Obama Administration came ...
(Date:2/23/2017)... ... February 23, 2017 , ... The American Cleft Palate-Craniofacial Association (ACPA) ... Meeting. KLS is a longtime supporter of the event. , "We are pleased ... Sponsor," said Dr. Bob Havlik, 2017 ACPA President. "KLS Martin has a long track ...
(Date:2/23/2017)... Mass. (PRWEB) , ... February 23, 2017 , ... ... as an approved content provider for the National Institute for Health and ... and social care-related organizations in the National Health Service (NHS) to search, order ...
(Date:2/23/2017)... ... , ... ERT, a global data and technology company that ... leading clinical development service provider, has selected ERT’s Trial Oversight suite as its ... to an array of circumstances including the use of multiple data capture modalities ...
Breaking Medicine News(10 mins):