SAN FRANCISCO, CA, Aug 11, 2010 (MARKETWIRE via COMTEX) --
Urigen Pharmaceuticals, Inc. (OTCQB: URGP), a specialty
pharmaceutical company focused on the development of treatments for
urological disorders and pain, announced it has formally requested a
Phase II Type C discussion with the FDA for its URG101 program for
Painful Bladder Syndrome/Interstitial Cystitis.
This interaction with the FDA is important for any new applicant
regarding the development or review of a new product by the FDA and
is expected to occur within 75 days. The Company continues to believe
that additional successful double blinded placebo controlled studies
may provide sufficient evidence of safety and efficacy to form the
clinical basis of an NDA submission.
William J. Garner, MD, CEO of Urigen Pharmaceuticals commented, "As
promised we have continued our efforts with the FDA and are pleased
to have prepared the Company for this formal request to advance our
regulatory requirements." Dr. Garner concluded, "The urgency to meet
with the FDA has increased in recent weeks as Pfizer announced it has
suspended its recent Tanezumab osteoarthritis clinical trial and
related studies, including those associated with Interstitial
About Urigen Pharmaceuticals, Inc.
Urigen Pharmaceuticals, Inc. is a specialty pharmaceutical company
dedicated to the development and commercialization of therapeutic
products for urological disorders. Urigen's two lead programs target
significant unmet medical needs and major market opportunities in
urology. Urigen's URG101, a proprietary combination of approved drugs
that is instilled into the bladder, targets painful bladder syndrome,
which affects approximately 10.5 million men and women in North
America. Urigen's URG301, a proprietary dosage form of an approved
drug that is locally delivered to control urinary urgency, targets
acute urgency in females diagnosed with an overactive bladder,
another major unmet need that is insufficiently managed by presently
available overactive bladder drugs. For further information, please
visit Urigen's website at http://www.urigen.com.
This press release may contain forward-looking statements. These
statements may be identified by the use of forward-looking
terminology such as "anticipate," "believe," "continue," "could,"
"estimate," "expect," "intend," "may," "might," "plan," "potential,"
"predict," "should," or "will," or the negative thereof or other
variations thereon or comparable terminology. Urigen has based these
forward-looking statements on current expectations, assumptions,
estimates and projections. While Urigen believes that these
expectations, assumptions, estimates and projections are reasonable,
such forward-looking statements are only predictions and involve
known and unknown risks and uncertainties, many of which are beyond
its control. Given these risks and uncertainties, investors and
security holders are cautioned not to place undue reliance on such
forward-looking statements. Urigen does not undertake any obligation
to update any such statements or to publicly announce the results of
any revisions to any such statements to reflect future events or
SOURCE: Urigen Pharmaceuticals, Inc.