The Population Council Inc, an international research organization based in New York, and Acrux Limited, the Australian pharma company specialising in administering drugs through the skin, announced positive results from the first clinical study of a novel contraceptive spray for women at BIO 2005 on Sunday.

The contraceptive skin spray has the potential advantages of not having to be taken at exactly the same time each day and being particularly suitable for breastfeeding mothers. Market research has shown that spray delivery is often preferred to oral or patch delivery.

The study was a Phase I, Proof-of-Concept, pharmacokinetic study, conducted in healthy women. The results showed that once-a-day dosing of the contraceptive spray Nestorone 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 Regine Sitruk-Ware, executive director of product research and development at the Population Council's Centre for Biomedical Research, New York, noted that potential advantages of Nestorone MDTS over existing methods of contraception are suitability to breast feeding mothers and women who cannot tolerate combined oral contraceptives containing oestrogens, increased flexibility in dosing time compared to progestogen-only pills, reduced skin irritation compared to patches, convenient daily dosing of the spray which leaves no visible residue on the skin.

The study was carried out under a joint development agreement between the Population Council and FemPharm on the transdermal spray delivery of the Population Council's Nestorone, a fourth-generation progestin which 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 licence to use Nestorone with its MDTS system.

Acrux is a specialty pharmaceutical company, developing and commercialising 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 clinical trials have been completed with 7 different drugs and the lead product, Evamist (Estradiol MDTS), is currently in a phase 3 trial in the USA.

The Population 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.