New Transdermal Contraceptive Spray In Development
(MELBOURNE 15 November 2004) - The Population Council, an international research
organization, and Acrux Limited (ASX: ACR), an Australian pharmaceutical company
that specializes in administering drugs through the skin, announced today the
start of the clinical study of a new type of contraceptive for women, the Nestorone®
Metered Dose Transdermal System® (MDTS®).
"We hope the development of Nestorone MDTS as a transdermal contraceptive
will offer women and couples a new option in meeting their family planning needs
with confidence and ease. This first study will provide us with the information
necessary before we begin the contraceptive efficacy trial," said Sandra
Arnold, the Population Council's vice president of corporate affairs.
Acrux CEO and managing director, Dr. Igor Gonda, said, "The commencement
of this study in collaboration with the Population Council, a world leader in
reproductive health research, is another step toward bringing to market the
world's first contraceptive spray product. Our transdermal spray would
be easy to use and would eliminate the need to swallow pills, take injections,
or wear patches."
According to Donnica Moore, MD, President and Founder of Sapphire Women's Health
Group and www.DrDonnica.com, "any new
development in the field of contraceptives will offer women and men additional
choices and additional options, which is a very good thing." She added that
"it must be noted that while exciting, research on this product is in the very
early clinical stages".
The Population Council and Acrux have a joint development agreement on the transdermal
spray delivery of Nestorone. The 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 the drug is slowly absorbed
into the bloodstream. MDTS will deliver the Population Council's Nestorone,
a fourth-generation progestin.
The study is sponsored by FemPharm Pty Ltd., a wholly owned subsidiary of Acrux
Ltd. Principal investigators are Professor Ian Fraser of the University
of Sydney's Queen Elizabeth II Research Institute for Mothers and Infants, Sydney,
Australia, and Dr. Edith Weisberg, director of research, FPA Health, Ashfield,
Australia.
"FemPharm is conducting an initial Phase 1 Proof of Concept pharmacokinetic
study in eight healthy women to establish the effective dosage required for
fertility control," said Weisberg. The study will be carried out
at the Sydney Centre for Reproductive Health Research and the Woolcock Institute
for Medical Research at the Royal Prince Alfred Hospital, Sydney, Australia.
The Population Council,
an international, not-for-profit, non-governmental organization, seeks to improve
the well-being and reproductive health of current and future generations around
the world and to help achieve a humane, equitable, and sustainable balance between
people and resources. The Council conducts biomedical, social science,
and public health research and helps build research capacities in developing
countries. Established in 1952, the Council is governed by an international
board of trustees. Its New York headquarters supports a global network of regional
and country offices. The Population Council has successfully developed contraceptives
and worked to make them accessible to people in developing countries. Three
of the four major long-lasting reversible contraceptives available today were
developed by the Population Council: the Copper T IUD, Norplant®, and Mirena®.
More than 50 million Copper T IUDs have been distributed in over 70 countries.
For more information on contraception, click here.
Created: 11/19/2004 - Donnica Moore, M.D.
