A new contraceptive spray currently in clinical trials is showing positive results in patients, according to Australian drug maker Acrux. The company’s Nestorone MDTS is a fourth-generation progestin contraceptive that has no androgenic hormonal effects and a good safety profile. The spray is a small, hand-held, easy-to-use spray designed to provide an easy and convenient means to deliver a preset dose of therapeutic drug directly to the skin. It is being touted by its maker as a “better choice” for women using hormonal contraceptive pills or patches.
The clinical trails were held in Australia with 40 women testing a number of skin spray formulations to the forearm once a day over 14 days. The formulations contained the proprietary new generation progestin Nestorone combined with either ethinyl estradiol or estradiol as the estrogen. The amount of each of these hormones in the blood was measured once a day and every four hours on day 14.
These were the first trials to test the performance of daily sprays over an extended period of time. Earlier trials tested only single doses of Nestorone MDTS formulations. Trial results showed that formulations containing Nestorone and ethinyl estradiol successfully delivered therapeutic amounts of both hormones across the skin into the blood. All spray formulations were well tolerated with no serious adverse events recorded, according to the drug maker.
The next step is expected to be a Phase 2 dose-ranging clinical trial before conducting Phase 3 global registration trials.