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Allendale Pharmaceuticals Announces FDA Approval Of The Today(R) Sponge; Contraceptive Returns To Market


10/19/2005 5:11:02 PM

ALLENDALE, N.J., April 22 /PRNewswire/ -- After an 11-year hiatus, the Today(R) Sponge, once the most popular over-the-counter female contraceptive, has won re-approval for marketing from the Food and Drug Administration. From 1983 to 1994, when the Today(R) Sponge was previously available in the U.S., more than 250 million Sponges were sold. Allendale plans to begin U.S. production immediately, and will begin national product distribution in summer 2005.

(Photo: http://www.newscom.com/cgi-bin/prnh/20050422/DCF038 )

The previous Sponge manufacturer, American Home Products, stopped making the Today(R) Sponge in 1994, along with other products, due to complications with its production facilities. The move to halt production was an economic decision, unrelated to safety of the Sponge.

Allendale Pharmaceuticals, a New Jersey-based consumer health care products company, bought the rights to the Today(R) Sponge in 1998 and has been navigating the FDA approval process ever since. Today's announcement means women in the United States will once again have access to this effective, hormone-free, contraceptive choice.

Despite its absence from store shelves for the past decade, the Today(R) Sponge still enjoys strong customer demand. "Daily calls and e-mails from women confirm that there is still a great need for the Today(R) Sponge", said Gene Detroyer, President and CEO of Allendale Pharmaceuticals. "Women who cannot tolerate hormonal contraceptives or choose not to use them are particularly pleased by the return of the Sponge." American women have been anticipating the re-approval of the Today(R) Sponge in the United States following its release in Canada in 2003. There has been heavy activity on the Today(R) Sponge hotline (888-343-4499) and on the company Web site (http://www.todaysponge.com/). The Today(R) Sponge is the first of several products to be marketed under the Today(R) brand, a division of Allendale Pharmaceuticals.

Consumers, gynecologists, and family planning groups are hailing the return of the Today(R) Sponge. Dr. Anne Davis, Assistant Professor of Clinical Obstetrics and Gynecology at Columbia University said, "As a practitioner, I can tell you that many women are looking forward to the return of the Sponge. Women need different contraceptive methods at different points in their lives. Women who have used the Today(R) Sponge describe it as easy-to-use, convenient, and safe. It's important to have a variety of contraceptive options available to all women."

  BENEFITS of the TODAY(R) SPONGE

   * Contains no hormones
   * Available over-the-counter, no prescription or doctor visit needed
   * Disposable, gives women control over contraception
   * Convenient; one size fits all
   * No messy foams or gels needed
   * A single Sponge can be used for 24 hours through repeated acts of
      intercourse
   * Generally undetectable by either partner
   * Instantly reversible so users can choose when they want protection and
      when they don't

  EFFECTIVENESS

Clinical studies on more than 1,800 women have shown the Today(R) Sponge is 89-91% effective at preventing pregnancy when used as directed, an effectiveness rate similar to other female over-the-counter contraceptives. The clinical trials were conducted at 26 sites in nine countries including the United States. During typical use, women using the Today(R) Sponge can expect birth control effectiveness that is comparable to the male condom. "Based on clinical studies conducted on women using the Today Sponge, an estimated 230,000 acts of intercourse resulted in 179 pregnancies," said Dr. Robert Staab, Chairman and Chief Scientific Officer of Allendale Pharmaceuticals. These results reflect those who used the product perfectly as well as those who did not use the Sponge correctly or did not use the Sponge with every act of intercourse. It is important to understand the effectiveness rate is based on one year of Sponge use and does not mean that the product fails about every tenth use. During the year of perfect and imperfect use by couples in these FDA-reviewed clinical studies, one pregnancy resulted from about 1000 acts of intercourse.

HOW IT WORKS

Unique in its design, the Today(R) Sponge was the first successful product to incorporate a spermicide into a barrier contraceptive. The Today(R) Sponge is a reservoir for one gram of Nonoxynol-9, the most widely used spermicide in the world. The advantages of the Today(R) Sponge are that it works to prevent pregnancy in three ways:

   * Through a patented design, it continually releases an effective amount
     of spermicide (125-150mg) to kill sperm.

   * It acts as a physical barrier between sperm and the cervix.

   * The polyurethane foam helps to trap and absorb semen.

Other advantages of the Today(R) Sponge include the fact that it contains no hormones and it allows women to take control of contraception. Once inserted, the Today(R) Sponge is effective immediately and remains effective for 24 hours without the need for applications of messy spermicidal creams, foams or gels. A single Today(R) Sponge allows for as many acts of intercourse as desired within a 24-hour timeframe without the need to change protection.

For maximum protection against pregnancy, the Today(R) Sponge must be left in place for at least six hours after the last act of intercourse. It should not remain inserted for more than 30 hours. The Today(R) Sponge does not protect against sexually transmitted diseases. Those at risk for STDs should use a condom in conjunction with the Today(R) Sponge for maximum protection against STDs and pregnancy. For more information about the Today(R) Sponge, visit http://www.todaysponge.com/. Consumers wishing to track availability should email Allendale at questions@todaysponge.com

Allendale Pharmaceuticals, Inc. was established in 1997 by Dr. Robert Staab and Gene Detroyer. The New Jersey-based company is dedicated to serving the health needs of women. In an expansion of the Today(R) brand, over the next year Allendale plans to release a new line of personal lubricants for women as well as other innovative reproductive health products.

Photo: NewsCom: http://www.newscom.com/cgi-bin/prnh/20050422/DCF038AP Archive: http://photoarchive.ap.org/AP PhotoExpress Network: PRN7PRN Photo Desk, photodesk@prnewswire.comAllendale Pharmaceuticals, Inc.

CONTACT: Paul Moniz, Paul.Moniz@widmeyer.com, or Bernice Manallo,Bernice.Manallo@widmeyer.com, +1-212-260-3401, both of WidmeyerCommunications, for Allendale Pharmaceuticals, Inc.


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