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Title:

Press Release

Entities:

Columbia Laboratories Inc.; University of California, Los Angeles

Date:

2003

Size:

9KB total

Price:

$36

ID:

#283982

 

 

► Miscellany ► News ► Press Releases ► Misc. Press Releases
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NEWS

    

Media Contact:

   MCS: Jamie DiGiovanni, (908) 234-9900, ext 43

Investor Relations:

   The Trout Group: Ritu Baral, (212) 477-9007, ext 25

Company Contacts:

   Columbia Laboratories, Inc.
     James Apostolakis, Vice Chairman
     (212) 588-1900
     David Weinberg, Chief Financial Officer
     (973) 994-3999

 

FOR IMMEDIATE RELEASE

 

U.S. FDA APPROVES STRIANT, A NEW TREATMENT FORM FOR MEN WITH A DEFICIENCY OR ABSENCE OF TESTOSTERONE, FROM COLUMBIA LABORATORIES

 

Striant offers a unique treatment option for the four to five million men in the United States who suffer from hypogonadism

 

LIVINGSTON, N.J.June 20, 2003 Columbia Laboratories, Inc. (AMEX: COB) today announced that the U.S. Food and Drug Administration (FDA) has approved Striant (testosterone buccal system) mucoadhesive (CIII), the first-ever transbuccal (gum surface) treatment for testosterone replacement therapy in men for conditions associated with a deficiency or absence of endogenous testosterone, including hypogonadism. Striant offers a safe, effective and convenient option in testosterone replacement therapy for the nearly five million men suffering from a deficiency or absence of testosterone.

 

(more)

 


Testosterone deficiencies are seen in men of all ages, with a significant number of sufferers experiencing symptoms over age 60, said Christina Wang, MD, Professor of Medicine, Harbor-UCLA Medical Center and aninvestigator in the clinical studies for Striant. In most patients in the clinical trials, Striant rapidly achieved and maintained a steady, consistent level of testosterone within 10 to 12 hours of initiating therapy.

 

We are pleased and excited to bring to market an innovative new product for the millions of men suffering from low testosterone, stated Fred Wilkinson, Columbias chairman, president and chief executive officer. Striants novel delivery mechanism, which provides controlled and sustained therapeutic levels of testosterone, offers an attractive treatment option for many patients. Wilkinson also states that Columbia Laboratories will begin shipping Striant to distributors in early third quarter, 2003.


 

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