Antares and Population Council initiate Phase II study of contraceptive ATD gel

The new contraceptive candidate uses Antares advanced transdermal delivery (ATD) gel system, which is a clear and cosmetically acceptable drug delivery gel. After application, the drug is slowly absorbed across the skin into the systemic circulation., the company said.

The current Phase II trial will determine the lowest safe and effective dose to suppress ovulation. The trial, which involves both US and international study sites, will evaluate three active strengths of the combination gel in 18 healthy, ovulating women. At different times during the course of the study, each woman will receive different dosages, with appropriate washout periods between doses.

According to the company, past studies showed that women using Nestorone experienced fewer side effects, such as acne, weight gain, and altered cholesterol levels, that are often experienced by women who use other common progestins.

Under the terms of the joint development agreement, Antares is responsible for R&D activities as they relate to ATD formulation and manufacturing, using the Population Council’s patented and other proprietary information covering the compound. The Population Council is responsible for research on Nestorone and clinical trial design, and management. The parties expect to identify a worldwide or regional commercial development partner together.

Paul Wotton, president and CEO of Antares, said: “We are very pleased to initiate this Phase II study with the Population Council for the Nestorone/ estradiol ATD gel.”