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Watson Announces Silodosin NDA Accepted For Filing By FDA For The Treatment Of Benign Prostatic Hyperplasia
Watson
Pharmaceuticals, Inc. (NYSE: WPI), a leading specialty pharmaceutical
company, announced that its New Drug Application (NDA) for silodosin,
a novel alpha(1)- adrenoreceptor antagonist, has been accepted for filing
by the U.S. Food and Drug Administration (FDA). Watson is seeking marketing
approval of silodosin from the FDA for the treatment of the signs and
symptoms associated with benign prostatic hyperplasia (BPH), or enlarged
prostate. Watson anticipates that the FDA will take action on its
application in the fourth quarter 2008.
Silodosin was designed to decrease urinary resistance and improve
dysuria (difficulty or pain in urination) associated with BPH. In clinical
trials, silodosin demonstrated a very low level of the most highly-reported
cardiovascular and blood pressure-related side effects associated with
existing BPH treatments, including dizziness and first-dose syncope
(fainting).
"This filing highlights Watson's capabilities in new drug development
and our commitment to this product, providing solutions to the millions of
men with BPH symptoms," said Paul Bisaro, Watson's President and Chief
Executive Officer. "Watson is expanding the portfolio it offers to
urologists and their patients, focusing on symptom management that makes a
big difference in their day-to-day lives."
Watson submitted the filing for silodosin with data from two Phase 3
multi-center (88 sites), randomized, double-blind, placebo-controlled
trials that evaluated a total of 923 patients with signs and symptoms of
BPH for 12 weeks. The trials demonstrated that a once daily 8mg dose of
silodosin given for 12 weeks provided significant relief of BPH symptoms,
compared with placebo, as measured by the International Prostate Symptom
Score (IPSS), the primary endpoint. Secondary endpoints included
improvements of maximum urine flow and quality of life. As expected, the
most common side effects seen in the two studies greater than 2% were
retrograde ejaculation (reduced semen) and dizziness.
Silodosin is highly uroselective for the alpha (1A) receptors located
in the prostate and bladder neck. Blocking these receptors relaxes the
smooth muscles, resulting in an improvement in urine flow and a reduction
in BPH symptoms. The selective binding of silodosin to the alpha (1A)
receptors is substantially greater than the binding to the
cardiovascular-associated alpha (1B) receptors and thereby maximizes target
organ activity while minimizing the potential for blood pressure effects.
The compound was originally developed by Kissei Pharmaceutical Co.,
Ltd., in Japan and licensed to Watson for the United States, Canada and
Mexico. Kissei successfully launched Urief(R) (silodosin) in Japan in May
of 2006 at a twice daily dosing of 4mg. Urief(R) is marketed in cooperation
with Daiichi Sankyo Pharmaceutical Co., Ltd.
BPH, or an enlarged prostate, is a condition found only in men and is
characterized by a non-cancerous enlargement of the prostate gland.
Symptoms of BPH include urinary difficulty, urinary frequency and an
inability to complete bladder emptying. The number of BPH patients has been
increasing with the expansion of the elderly population. In the United
States, BPH affects more than half of men in their 60's and as many as 90
percent of men by the age of 85. According to IMS data, BPH symptoms were
the primary reason patients visited their urologists in 2006.
About Watson Pharmaceuticals, Inc.
Watson Pharmaceuticals, Inc., headquartered in Corona, California, is a
leading specialty pharmaceutical company that develops, manufactures,
markets, sells and distributes brand and generic pharmaceutical products.
Watson pursues a growth strategy combining internal product development,
strategic alliances and collaborations and synergistic acquisitions of
products and businesses.
Watson is committed to providing innovative solutions in urology care.
With seven products currently available to address conditions ranging from
overactive bladder to prostate cancer, Watson continues to support research
that not only treats the symptoms associated with urological conditions,
but that helps make urology patients' lives more livable. The Watson
portfolio in the U.S. includes Oxytrol(R); Trelstar(R) LA; Trelstar(R)
Depot; Androderm(R); AndroGel(R), under a co-promotion agreement with
Solvay Pharmaceuticals, Inc.; and ProQuin(R) XR, under a co-promotion
agreement with Depomed, Inc. In addition to silodosin, the Watson urology
portfolio includes a number of products under development; Uracyst(R), for
the treatment of interstitial cystitis; a six-month formulation of
Trelstar(R) (triptorelin pamoate for injectable suspension), for the
treatment of advanced prostate cancer; and oxybutynin topical gel, for
overactive bladder.
For press releases and other company information, visit Watson
Pharmaceuticals' Web site at http://www.watson.com.
About Kissei Pharmaceutical Co., Ltd.
Kissei Pharmaceutical Co., Ltd., headquartered in Matsumoto, Nagano
prefecture, founded in 1946, is a Japanese pharmaceutical company that
develops, manufactures, markets, sells and distributes brand pharmaceutical
products. Kissei is primarily focused on three important fields of new drug
research: urogenital, endocrinology & metabolism and immunology & allergy.
Forward-Looking Statement
Any 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, the difficulty of predicting
the timing or outcome of clinical studies, product development efforts and
FDA or other regulatory agency approvals or actions; whether the results of
clinical trials for silodosin and other information will be sufficient to
support approval by FDA and other regulatory authorities; delays regarding
the regulatory approval process, including the timing and scope of approval
received, if any; market acceptance and continued demand for Watson's
products, including silodosin, if approved; our ability to successfully
defend and/or enforce our patents and other intellectual property rights
against third parties; patents and other intellectual property rights held
by competitors and other third parties; successful compliance with FDA and
other governmental regulations applicable to Watson's products and/or
business; and such 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, 2006.
Watson Pharmaceuticals, Inc.
http://www.watson.com
View drug information on Androderm; AndroGel testosterone gel; Oxytrol.
Watson anunta Silodosin NDA acceptate pentru depunerea de cãtre FDA pentru tratamentul de hiperplazia benigne Prostatic - Watson Announces Silodosin NDA Accepted For Filing By FDA For The Treatment Of Benign Prostatic Hyperplasia - articole medicale engleza - startsanatate