Navigation Links
Cerimon Pharmaceuticals Initiates Phase III Clinical Studies to Evaluate Its Topical Diclofenac Sodium Patch for Mild-to-Moderate Pain
Date:2/25/2009

SAN FRANCISCO, Feb. 25 /PRNewswire/ -- Cerimon Pharmaceuticals, Inc., announced today the Company has enrolled its first subjects in its once-daily topical diclofenac sodium patch Phase III program. The program consists of three randomized, double-blind, placebo-controlled Phase III clinical studies with Cerimon's diclofenac patch. The studies will assess the efficacy and safety of Cerimon's diclofenac patch compared to placebo for the treatment of acute pain caused by mild-to-moderate ankle sprains, wrist injuries and soft tissue injuries of the upper and lower extremities. The ankle sprain and wrist injury studies will each enroll 208 subjects, and the soft tissue injury study will enroll 400 subjects. All three studies will randomize subjects to receive Cerimon's topical diclofenac sodium patch or placebo at a ratio of 1:1.

"Results from our Phase II acute ankle sprain study have demonstrated our topical diclofenac patch can deliver effective relief of acute pain due to mild-to-moderate musculoskeletal injuries without the side effects often associated with oral NSAIDs," stated James S. Shannon, M.D., Chief Executive Officer of Cerimon Pharmaceuticals. "Based on these data, we believe our diclofenac patch will be able to address the growing physician and patient interest in prescription therapies that can deliver safe, effective and convenient site-specific pain management."

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 pain and inflammation. Cerimon's lead product, its topical diclofenac patch, has begun its Phase III program, which includes three studies for the treatment of mild-to-moderate pain due to acute ankle sprain, wrist injury or soft tissue injury. The Company initiated its pivotal program based on positive results from Cerimon's Phase II SUPPORT (Stop Underlying Pain with a diclofenac Patch and Obtain Relief Topically) ankle sprain study. A topical diclofenac lotion is also in development.

Cerimon is financed by the premier investors MPM, Normura Phase4 and OrbiMed Advisors. For more information on Cerimon, please visit the Company's website at http://www.cerimon.com.


'/>"/>
SOURCE Cerimon Pharmaceuticals, Inc.
Copyright©2009 PR Newswire.
All rights reserved

Related biology technology :

1. Cerimon Pharmaceuticals to Present at the 2007 BIO Investor Forum
2. Cerimon Pharmaceuticals Names Matthew J. Meyer its General Counsel and Vice President of Business Development and Licensing
3. Cerimon Pharmaceuticals Appoints James S. Shannon, M.D., to Board of Directors
4. Vion Pharmaceuticals Pays Interest on 7.75% Convertible Senior Notes
5. China Biopharmaceuticals Holdings Announces Second Quarter 2007 Financial Results
6. Vion Pharmaceuticals Completes Accrual of 85 Patients to its Pivotal Phase II Trial of Cloretazine(R) (VNP40101M) in Elderly AML
7. XTL Biopharmaceuticals Announces Financial Results for the Six Months Ended June 30, 2007
8. Cadence Pharmaceuticals Reports Second Quarter 2007 Financial Results
9. Nabi Biopharmaceuticals to Present at Upcoming Industry Conferences
10. Anadys Pharmaceuticals Appoints Steve Worland, Ph.D. as President and Chief Executive Officer
11. Poniard Pharmaceuticals Announces Participation in Upcoming Conferences
Post Your Comments:
*Name:
*Comment:
*Email:
(Date:5/25/2016)... ... May 25, 2016 , ... ... issued by the Office of the National Coordinator for Health IT (ONC) outlining ... if clinically relevant data were available when and where it was needed. The ...
(Date:5/25/2016)... , ... May 25, 2016 , ... ... Food and Drug Administration (FDA) has granted the company’s orphan drug designation request ... second orphan drug designation granted by the FDA. , Spinocerebellar ataxia is ...
(Date:5/24/2016)... (PRWEB) , ... May 24, 2016 , ... ... a newly re-branded identity. The new Media Cybernetics corporate branding reflects a results-driven ... of imaging and image analysis. The re-branding components include a crisp, refreshed logo ...
(Date:5/23/2016)... , May 23, 2016 Oxitec CEO ... th at 10:15 a.m. ET before the United States ... genetically engineered mosquitos can play in controlling the spread of ... the Zika virus.      (Logo: http://photos.prnewswire.com/prnh/20150630/227348 ... mosquito with a self-limiting gene. Trials in Brazil ...
Breaking Biology Technology:
(Date:4/26/2016)... LONDON , April 26, 2016 ... EdgeVerve Systems, a product subsidiary of Infosys (NYSE: ... a partnership to integrate the Onegini mobile security ... (Logo: http://photos.prnewswire.com/prnh/20151104/283829LOGO ) The ... enhanced security to access and transact across channels. ...
(Date:4/15/2016)... CHICAGO , April 15, 2016  A ... companies make more accurate underwriting decisions in a ... offering timely, competitively priced and high-value life insurance ... health screenings. With Force Diagnostics, rapid ... and lifestyle data readings (blood pressure, weight, pulse, ...
(Date:4/13/2016)... , April 13, 2016  IMPOWER physicians supporting ... are setting a new clinical standard in telehealth thanks ... By leveraging the higi platform, IMPOWER patients can routinely ... pulse and body mass index, and, when they opt ... and convenient visit to a local retail location at ...
Breaking Biology News(10 mins):