Spray on contraceptive clears Phase I trial

In collaboration with the New York, US-based research group The Population Council, the company has reported positive results from the first clinical study of a novel contraceptive spray, called Nestorone MDTS.

The results of the Phase I pharmacokinetic study showed that once-a-day dosing of the contraceptive spray Nestorone MDTS provided sustained delivery of the contraceptive agent.

Average serum concentrations of Nestorone - a fourth-generation progestin which is not absorbed when administered by mouth.- were maintained in the target range expected to be effective for contraception, while the spray was well tolerated, with no serious adverse events recorded, they said.

The technology underpinning the product, dubbed the Metered Dose Transdermal System (MDTS), is a spray device used in tandem with small, lipid-like compounds which help drugs to pass through the skin called ACROSS enhancers. The device is placed gently against the skin and activated, releasing a light spray which quickly dries on the skin. A once a day application typically delivers consistent amounts through the skin to the blood stream.

The contraceptive skin spray has the potential advantages of not having to be taken at exactly the same time each day and being suitable for breast feeding mothers, according to Acrux, which also said the system has reduced skin irritation compared to patches.

With its transdermal systems, Acrux targets a market that is already worth around $3 billion (€2.45bn) a year in the US alone and is growing at a rapid pace.

The reason is that transdermal delivery of drugs not only overcomes the main problem with oral or intravenous dosing - making sure patients actually take their drugs - but also avoids issues such as drastic changes in pH that accompany oral dosing, variable transit times in the gut, and rapid fluctuations in plasma concentrations.