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MEDIA CENTER Clinical Trial of the World’s First Contraceptive Spray for Women: Acrux and Population Council Announce Positive Data MELBOURNE and PHILADELPHIA (20 June 2005) — The Population Council, an international research organization based in New York, and Acrux Limited, an Australian pharmaceutical company that specializes in administering drugs through the skin, today announced positive results from the first clinical study of a novel contraceptive spray for women. The study was a Phase I, proof-of-concept, pharmacokinetic study conducted in six healthy women. The results showed that once-a-day dosing of the contraceptive spray Nestorone® Metered Dose Transdermal System® (MDTS®) provided sustained delivery of the contraceptive agent Nestorone. Mean serum concentrations of Nestorone were maintained in the target range expected to be effective for contraception. The spray was well tolerated, with no serious adverse events recorded. The trial results were presented at BIO 2005 in Philadelphia by Dr. Igor Gonda, CEO of Acrux Limited. Dr. Régine Sitruk-Ware, executive director of product research and development at the Population Council’s Center for Biomedical Research in New York City, noted that potential advantages of the Nestorone MDTS over existing methods of contraception, such as pills and patches, are:
Gonda said, “Nestorone MDTS is another product in our women’s health portfolio delivered as a daily spray. We believe that many women will prefer this method. Our transdermal sprays are easy to use and would eliminate the need to swallow pills, take injections, or wear patches.” The clinical study was sponsored by FemPharm Pty Ltd., a wholly owned subsidiary of Acrux Limited. Principal investigators were Ian Fraser, professor in reproductive medicine at the University of Sydney, Australia, and Dr. Edith Weisberg, director of research, Sydney Centre for Reproductive Health Research, Research Division of FPA Health, Sydney, Australia. The study was carried out under a joint development agreement between the Population Council and FemPharm on the transdermal spray delivery of the Council's Nestorone, a fourth-generation progestin that is not absorbed when administered by mouth. Acrux’s patented transdermal delivery system, MDTS, applies a pre-set dose of fast-drying formulation on the skin. This forms an invisible depot within the skin from which Nestorone is slowly absorbed into the bloodstream. The clinical study completes the primary obligations of the Population Council and FemPharm under the joint development agreement. The parties are currently negotiating an agreement under which FemPharm will obtain a license to use Nestorone with its MDTS system.
Acrux (www.acrux.com.au) is a specialty pharmaceutical company, developing and commercializing a range of patented, patient-preferred healthcare products for global markets, using its innovative technology to administer drugs through the skin. Acrux’s product pipeline includes treatments of hormonal deficiencies, pain, central nervous system disorders, and urinary incontinence, as well as a contraceptive. Seventeen human clinical trials have been completed with seven different drugs, and the lead product, Evamist™ (Estradiol MDTS®), is currently in a Phase III clinical trial in the United States. Acrux has licensed U.S. rights for Evamist (Estradiol MDTS) and Testosterone MDTS to VIVUS and AUS/NZ distribution rights for Testosterone MDTS and Fentanyl MDTS® to CSL Limited. Acrux has also licensed its technology to Eli Lilly for veterinary healthcare products, to Napa Biosciences for certain dermatology products, and to Connetics for anti-psoriatics and local anesthetics. Acrux contacts
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