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Message 12337592
TA
Message #22594 from Tunica Albuginea at Dec 22 1999 1:30PM
Mkilloran, you ain't kidding:
quote.bloomberg.com.
Business Editors/Health & Medical Writers
MOUNTAIN VIEW, Calif.--(BW HealthWire)--Dec. 22, 1999--VIVUS,
Inc. (Nasdaq:VVUS) announced today that is has filed a New Drug
Application ("NDA") for ALIBRA with the US Food and Drug
Administration ("FDA"). ALIBRA is VIVUS' second drug product for the
treatment of male erectile dysfunction ("ED"), commonly called
impotence.
ALIBRA, a local therapy, consists of two drugs, alprostadil and
prazosin HCl, formulated into a microsuppository and delivered to the
urethra (urine tube) via a single-use plastic applicator. ALIBRA is
effective within 5 to 10 minutes of application and has a duration of
action of 30 to 60 minutes.
"ALIBRA combines the safety benefits of local therapy with the
convenience of applying the first dose at home rather than in the
doctor's office," said Leland Wilson, president and chief executive
officer of VIVUS, Inc. "We believe these improved attributes will make
prescribing ALIBRA easier for Primary Care Physicians who currently
treat the majority of ED patients."
The safety and efficacy of ALIBRA was tested at 44 clinical sites
in the U.S. and included over 1,000 men, the majority of whom had
severe erectile dysfunction. In a two-month double-blind,
placebo-controlled study, the clinical efficacy of ALIBRA, as
demonstrated by the improved ability of patients to have sexual
intercourse successfully, was observed for men with diverse underlying
causes of ED, including vascular disease, diabetes, prostate surgery,
or medication side-effects.
With local therapies such as ALIBRA, effective levels of
medication can be delivered to the erectile tissues of the penis,
limiting exposure of the whole body to drug, thereby minimizing the
potential for systemic side effects. A drawback with currently
available local therapies is that they must be initiated under medical
supervision in order to determine the appropriate dosage level.
Because ALIBRA consists of a single, fixed combination of alprostadil
and prazosin HCl, "in office" dosing should not be necessary.
Commercial availability of ALIBRA and final product labeling are
dependent upon FDA review of this application. The actual clinical
data is expected to be presented at scientific meetings during 2000.
VIVUS, Inc. is the developer and manufacturer of MUSE(R)
(alprostadil) and ACTIS(TM), two innovations in the treatment of men
with erectile dysfunction. The Company's objective is to become a
global leader in the development and commercialization of innovative
therapies for the treatment of sexual dysfunction and urologic
disorders in men and women. VIVUS has ongoing research and development
programs in the areas of female sexual dysfunction and male premature
ejaculation.
Note to Editors: Additional written materials, recent releases
and Company information are available through a variety of sources,
including the VIVUS home page (www.vivus.com) and the VIVUS
Fax-On-Demand Service (1-888-329-5719.)
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TA
TA@ var.vet.uga.edu
cdhomem.com.br
vh.org
vh.org
vh.org
pacs.unica.it
caudit.edu.au.
caudit.edu.au.
echt.chm.msu.edu.
echt.chm.msu.edu.
caudit.edu.au.
.com
Still long on VVUS,
:-)
TA
Message #22590 from Mkilloran at Dec 12 1999 10:59PM
Susan...VVUS volume had a big rise on Friday...I expect that a lot of shorts will be covering in the near term...
VVUS has the potential to pay off big for patient investors
Waiting for good news on Alibra, PE oral drug and Female SD cream ....XMAS 2000 may be a very different story for VVUS investors.
It's a good time to buy more VVUS for the long haul at these prices....IMO
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