Carl R
02-27-2003, 10:09 AM
FDA Approves Watson's OXYTROL(TM), The First and Only Transdermal Therapy for Overactive Bladder
Wednesday February 26, 9:34 pm ET
CORONA, Calif., Feb. 26 /PRNewswire-FirstCall/ -- Watson Pharmaceuticals, Inc. (NYSE: WPI - News), announced today that the U.S. Food and Drug Administration (FDA) has approved OXYTROL(TM) (oxybutynin transdermal system), the first and only transdermal therapy to treat overactive bladder (OAB), with symptoms of urge urinary incontinence, urgency and frequency. Estimated to affect more than 33 million Americans, OAB is more common than both diabetes and asthma.
(Photo: http://www.newscom.com/cgi-bin/prnh/20020214/WATSONLOGO )
"The approval of OXYTROL(TM) marks an important milestone for Watson," said Allen Chao, Chairman and Chief Executive Officer. "As a company committed to developing products that enhance the standard of care for patients, we believe OXYTROL's(TM) innovative transdermal delivery will provide OAB sufferers with a much needed treatment option. In addition, OXYTROL's(TM) approval strengthens Watson's position as a leading generic and specialty brand pharmaceutical company."
Proven Efficacy with Anticholinergic Side Effects Comparable to Placebo
Clinical trials involving more than 1,000 subjects at over 50 U.S. centers showed that OXYTROL(TM) provides effective control of OAB symptoms over a three to four day period. Data also show that OXYTROL(TM) is well tolerated, with anticholinergic side effects, such as dry mouth and constipation, comparable to placebo. The most common adverse events occurring with OXYTROL(TM) were application site reactions.
"Side effects have long been a leading cause of treatment discontinuation among my patients suffering from overactive bladder," said Roger Dmochowski, M.D., Professor of Urology, Vanderbilt University and OXYTROL(TM) study investigator. "OXYTROL's(TM) transdermal delivery system provides physicians and patients with a convenient new treatment option to help manage the symptoms of overactive bladder with anticholinergic side effects comparable to a placebo patch. I am thrilled to have this important new treatment to offer my patients coping with this condition."
About OXYTROL
OXYTROL(TM) is a thin, flexible and clear patch that should be applied to the abdomen, hip or buttock twice weekly. The active ingredient in OXYTROL(TM) is oxybutynin, a medication widely accepted and prescribed in oral formulation for the past 25 years. OXYTROL's(TM) transdermal delivery system delivers 3.9 milligrams per day of oxybutynin consistently and continuously through the skin into the bloodstream, bypassing initial metabolism in the liver and the gastrointestinal tract that occurs with oral medications, providing relief of overactive bladder symptoms for up to four days. Patients who have urinary retention, gastric retention, uncontrolled narrow-angle glaucoma or hypersensitivity to oxybutynin or other components of OXYTROL(TM) should not use OXYTROL(TM).
About Overactive Bladder
OAB is defined as urgency, with or without urge incontinence and usually includes frequency and nocturia (waking up one or more times during the night to urinate). The condition is characterized by involuntary bladder muscle contractions that often times a patient cannot suppress, resulting in involuntary loss of urine. OAB can force patients to limit their participation in a myriad of physical and social activities, leaving sufferers feeling frustrated, anxious, embarrassed and sleep deprived.
For full prescribing information on OXYTROL(TM), please call 1-888-OXYTROL (1-888-699-8765).
Watson will host a conference call and webcast on Thursday, February 27, 2003 at 9:00 a.m. Eastern Standard Time to discuss the OXYTROL(TM) approval. The dial-in number to access the call is (877) 251-7980, or from international locations, (706) 643-1573. A taped replay of the call will be available by calling (800) 642-1687 with access pass code 8571330. The replay may be accessed from international locations by dialing (706) 645-9291 using the same pass code. This replay will remain in effect until midnight Eastern Standard Time, Wednesday, March 5, 2003. To access the live webcast, go to Watson's website at www.watsonpharm.com (http://www.watsonpharm.com) and click on the Investors icon.
Watson Pharmaceuticals, Inc. Watson Pharmaceuticals, Inc., headquartered in Corona, CA, is a leading specialty pharmaceutical company that develops, manufactures, markets and distributes branded and generic pharmaceutical products. Watson pursues a growth strategy combining internal product development, strategic alliances and collaborations and synergistic acquisitions of products and businesses.
Statements contained in this press release that refer to future events or other non-historical facts are forward-looking statements that reflect Watson's current perspective of existing trends and information as of the date of this release. Except as expressly required by law, Watson disclaims any intent or obligation to update these forward-looking statements. Actual results may differ materially from Watson's current expectations depending upon a number of factors affecting Watson's business. These factors include, among others, market acceptance of and continued demand for Watson's products; the impact of competitive products and pricing; patents and other intellectual property rights held by competitors and other third parties; successful compliance with governmental regulations; and other risks and uncertainties detailed in Watson's periodic public filings with the Securities and Exchange Commission, including but not limited to Watson's Annual Report on Form 10-K for the year ended December 31, 2001, and its Quarterly Reports on Form 10-Q for the quarters ended March 31, 2002, June 30, 2002 and September 30, 2002.
For press releases and other company information, please go to Watson Pharmaceuticals' website at http://www.watsonpharm.com .
--------------------------------------------------------------------------------
Source: Watson Pharmaceuticals, Inc.
link to article (http://biz.yahoo.com/prnews/030226/law122_1.html)
Wednesday February 26, 9:34 pm ET
CORONA, Calif., Feb. 26 /PRNewswire-FirstCall/ -- Watson Pharmaceuticals, Inc. (NYSE: WPI - News), announced today that the U.S. Food and Drug Administration (FDA) has approved OXYTROL(TM) (oxybutynin transdermal system), the first and only transdermal therapy to treat overactive bladder (OAB), with symptoms of urge urinary incontinence, urgency and frequency. Estimated to affect more than 33 million Americans, OAB is more common than both diabetes and asthma.
(Photo: http://www.newscom.com/cgi-bin/prnh/20020214/WATSONLOGO )
"The approval of OXYTROL(TM) marks an important milestone for Watson," said Allen Chao, Chairman and Chief Executive Officer. "As a company committed to developing products that enhance the standard of care for patients, we believe OXYTROL's(TM) innovative transdermal delivery will provide OAB sufferers with a much needed treatment option. In addition, OXYTROL's(TM) approval strengthens Watson's position as a leading generic and specialty brand pharmaceutical company."
Proven Efficacy with Anticholinergic Side Effects Comparable to Placebo
Clinical trials involving more than 1,000 subjects at over 50 U.S. centers showed that OXYTROL(TM) provides effective control of OAB symptoms over a three to four day period. Data also show that OXYTROL(TM) is well tolerated, with anticholinergic side effects, such as dry mouth and constipation, comparable to placebo. The most common adverse events occurring with OXYTROL(TM) were application site reactions.
"Side effects have long been a leading cause of treatment discontinuation among my patients suffering from overactive bladder," said Roger Dmochowski, M.D., Professor of Urology, Vanderbilt University and OXYTROL(TM) study investigator. "OXYTROL's(TM) transdermal delivery system provides physicians and patients with a convenient new treatment option to help manage the symptoms of overactive bladder with anticholinergic side effects comparable to a placebo patch. I am thrilled to have this important new treatment to offer my patients coping with this condition."
About OXYTROL
OXYTROL(TM) is a thin, flexible and clear patch that should be applied to the abdomen, hip or buttock twice weekly. The active ingredient in OXYTROL(TM) is oxybutynin, a medication widely accepted and prescribed in oral formulation for the past 25 years. OXYTROL's(TM) transdermal delivery system delivers 3.9 milligrams per day of oxybutynin consistently and continuously through the skin into the bloodstream, bypassing initial metabolism in the liver and the gastrointestinal tract that occurs with oral medications, providing relief of overactive bladder symptoms for up to four days. Patients who have urinary retention, gastric retention, uncontrolled narrow-angle glaucoma or hypersensitivity to oxybutynin or other components of OXYTROL(TM) should not use OXYTROL(TM).
About Overactive Bladder
OAB is defined as urgency, with or without urge incontinence and usually includes frequency and nocturia (waking up one or more times during the night to urinate). The condition is characterized by involuntary bladder muscle contractions that often times a patient cannot suppress, resulting in involuntary loss of urine. OAB can force patients to limit their participation in a myriad of physical and social activities, leaving sufferers feeling frustrated, anxious, embarrassed and sleep deprived.
For full prescribing information on OXYTROL(TM), please call 1-888-OXYTROL (1-888-699-8765).
Watson will host a conference call and webcast on Thursday, February 27, 2003 at 9:00 a.m. Eastern Standard Time to discuss the OXYTROL(TM) approval. The dial-in number to access the call is (877) 251-7980, or from international locations, (706) 643-1573. A taped replay of the call will be available by calling (800) 642-1687 with access pass code 8571330. The replay may be accessed from international locations by dialing (706) 645-9291 using the same pass code. This replay will remain in effect until midnight Eastern Standard Time, Wednesday, March 5, 2003. To access the live webcast, go to Watson's website at www.watsonpharm.com (http://www.watsonpharm.com) and click on the Investors icon.
Watson Pharmaceuticals, Inc. Watson Pharmaceuticals, Inc., headquartered in Corona, CA, is a leading specialty pharmaceutical company that develops, manufactures, markets and distributes branded and generic pharmaceutical products. Watson pursues a growth strategy combining internal product development, strategic alliances and collaborations and synergistic acquisitions of products and businesses.
Statements contained in this press release that refer to future events or other non-historical facts are forward-looking statements that reflect Watson's current perspective of existing trends and information as of the date of this release. Except as expressly required by law, Watson disclaims any intent or obligation to update these forward-looking statements. Actual results may differ materially from Watson's current expectations depending upon a number of factors affecting Watson's business. These factors include, among others, market acceptance of and continued demand for Watson's products; the impact of competitive products and pricing; patents and other intellectual property rights held by competitors and other third parties; successful compliance with governmental regulations; and other risks and uncertainties detailed in Watson's periodic public filings with the Securities and Exchange Commission, including but not limited to Watson's Annual Report on Form 10-K for the year ended December 31, 2001, and its Quarterly Reports on Form 10-Q for the quarters ended March 31, 2002, June 30, 2002 and September 30, 2002.
For press releases and other company information, please go to Watson Pharmaceuticals' website at http://www.watsonpharm.com .
--------------------------------------------------------------------------------
Source: Watson Pharmaceuticals, Inc.
link to article (http://biz.yahoo.com/prnews/030226/law122_1.html)