Navigation Links
Xanodyne Receives Approval From the U.S. Food and Drug Administration for ZIPSOR(TM) (diclofenac potassium) Liquid Filled Capsules
Date:6/17/2009

NEWPORT, Ky., June 17 /PRNewswire/ -- Xanodyne Pharmaceuticals, Inc. announced today that it has received approval from the U.S. Food and Drug Administration (FDA) for Zipsor (diclofenac potassium) Liquid Filled Capsules, a new treatment option indicated for relief of mild to moderate acute pain in adults (18 years of age or older).

"Zipsor is a drug with several unique features," said Gary A. Shangold, Chief Medical Officer of Xanodyne. "It is the first NSAID to be approved based on the demonstration of safety and efficacy in two well controlled post-surgical bunionectomy clinical trials and accomplished this with the lowest available dose (25 mg) of any currently marketed diclofenac potassium product in the United States. It will also be the first and only prescription strength NSAID for oral administration available for the U.S. market in a liquid-filled soft gelatin capsule," continued Dr. Shangold.

The low recommended total daily dose of diclofenac potassium delivered with Zipsor aligns with current guidance from the FDA recommending utilization of NSAIDs at the lowest effective dose, for the shortest amount of time. Zipsor was generally well-tolerated and demonstrated efficacy in two multiple dose post-surgery (bunionectomy) clinical trials. At baseline, Zipsor patients had an average pain intensity of 6.9 (on a 0 to 10 numeric pain rating scale).

"Demonstrating efficacy at a low dose not previously available to the market presents an important new therapeutic option to the physician and a significant opportunity for Xanodyne. It is also a significant milestone for our company as Zipsor represents the first approval to come out of our R&D organization. We are completing our launch preparations and our expectation is to have Zipsor on the US market within the coming months," said Michael Valentino, President and Chief Executive Officer.

Important Safety Information about Zipsor

Like all prescription non-steroidal anti-inflammatory drugs (NSAIDs), Zipsor may increase the chance of a heart attack or stroke that can lead to death. Zipsor should not be used right before or after certain heart surgeries. Serious skin reactions or stomach and intestine problems, such as bleeding and ulcers, can occur without warning and may cause death. Patients taking aspirin or other blood thinners and the elderly are at increased risk for stomach bleeding and ulcers. Tell your doctor about all of the medications you take and all of your medical conditions prior to taking Zipsor, especially if you are pregnant, have a history of ulcers or bleeding in the stomach or intestines, have high blood pressure or heart failure or heart disease, or have kidney or liver problems. People with aspirin-sensitive asthma or allergic reactions due to aspirin or other NSAIDs should not take Zipsor. Prescription Zipsor should be used exactly as prescribed at the lowest possible dose for the shortest time needed. For additional important information about Zipsor see the FDA-approved medication guide or the full prescribing information.

About Xanodyne

Xanodyne Pharmaceuticals, Inc., which commenced operations in 2001, is an integrated specialty pharmaceutical company with both development and commercial capabilities focused on women's healthcare and pain management. Xanodyne markets a portfolio of revenue generating products consisting of prescription pharmaceuticals and a line of prenatal vitamins. Additionally, Xanodyne is advancing a late stage pipeline of product candidates targeted at significant potential markets in Xanodyne's focus areas.


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

Related medicine news :

1. Xanodyne Announces Appointment of Mr. Vaughn M. Kailian of MPM Capital to the Board of Directors
2. Xanodyne Announces New President/CEO and Completes $38 Million Equity Financing
3. Xanodynes New Drug Application for the Treatment of Heavy Menstrual Bleeding (Menorrhagia) Accepted for Filing with a Priority Review Classification
4. Epeius Biotechnologies Rexin-G Receives FDA Fast Track Designation for the Treatment of Pancreatic Cancer
5. STAAR Surgical Receives Japanese Clearance for the KS-Ni Preloaded IOL Injector System
6. Herzing University, Minneapolis Receives Board of Nursing Approval
7. Steelcase Inc. Receives Five Best of NeoCon Awards and Best Overall Showroom for Nurture at NeoCon 2009
8. President Obama Receives Warm Welcome from AMA Physicians
9. Biomerix Corporation Receives ISO 13485 Certification
10. Instrumentation Laboratory Receives 510(k) Clearance From FDA for HemosIL(R) Liquid Heparin Assay
11. Endologix Receives Nasdaq Letter on Director Independence
Post Your Comments:
*Name:
*Comment:
*Email:
(Date:5/27/2016)... , ... May 27, 2016 , ... W.S. Badger ... announced today that it has been recognized as one of the best small businesses ... was named as one of nine small businesses providing progressive benefits to new parents ...
(Date:5/27/2016)... NY (PRWEB) , ... May 27, 2016 , ... ... with Mediaplanet to help educate the many who are unaware of the plight ... to aphasia will run within the “Stroke Awareness” campaign. , The link between ...
(Date:5/27/2016)... ... May 27, 2016 , ... ... in the pharmaceutical, medical and food industries. Aside from its GMP accreditation, Validation ... providing proof of successfully certified products, services and staff. , Validation Center is ...
(Date:5/26/2016)... ... May 26, 2016 , ... Intalere, ... members and suppliers for its inaugural Member Conference at the Paris Hotel in ... elevating the operational health of America’s healthcare providers. , The conference was highlighted ...
(Date:5/26/2016)... ... May 26, 2016 , ... Cardiac arrhythmia ... negative impact on long-term patient survival, reports a team of UPMC researchers in ... week in the Journal of Thoracic and Cardiovascular Surgery, provide critical information that ...
Breaking Medicine News(10 mins):
(Date:5/25/2016)... May 25, 2016 According to ... Type (3D, 2D, 4D), by Therapeutic Area (Oncology, Cosmeceutical/Plastic ... User (Medical Device Manufacturers, Hospitals/ Clinics) - Forecast to ... Medical Animation Market for the forecast period of 2016 ... 301.3 Million by 2021 from USD 117.3 Million in ...
(Date:5/25/2016)... 25, 2016 According to market ... Growth and Demand Forecast to 2022 - Industry Insights ... Others)" published by P&S Market Research, the global insulin ... 2015, and it is expected to grow at a ... insulin pump segment is expected to witness the fastest ...
(Date:5/25/2016)... England , May 25, 2016 ... company employing the precision of circulating tumour DNA ... today announces the appointment of Professor Clive ... provide medical leadership across the clinical development programme, ... Inivata,s products help deliver significant improvements in clinical ...
Breaking Medicine Technology: