Antares Pharma, Inc. (AMEX:AIS) and the Population Council have initiated a Phase I pharmacokinetic clinical program in twelve healthy, post-menopausal women using Antares’ ATD™ transdermal gel to deliver nestorone and estradiol in two separate treatment periods. In the first period there will be a single administration of two different doses of nestorone concurrently with estradiol and in the second treatment period the most effective combined dose of nestorone and estradiol will be tested as once daily dosing for ten consecutive days. The primary objectives of the studies include determining the pharmacokinetic profile of the nestorone component of the nestorone/estradiol combination ATD™ gel delivered transdermally and determining the necessary nestorone dose to achieve the appropriate therapeutic levels for effective contraception. Secondary objectives include determining the profile of estradiol needed to reach estrogen replacement levels and to maintain regular bleeding patterns and evaluating local skin irritation and tolerability of the nestorone/estradiol combination ATD™ gel.
Current research in the U.S. from the National Survey of Family Growth has revealed that 31% of women discontinue use of reversible contraceptives for method-related reasons within six months of starting use, and 44% do so within 12 months. This high rate of method-related discontinuation suggests considerable dissatisfaction with available methods. Furthermore, these statistics indicate that even with the recent advent of novel hormonal contraceptive delivery systems there is still a need for more options to prevent unintended pregnancies. The need is heightened in the developing world where dissatisfaction with methods is compounded by access, cost and sociocultural issues. Additionally there are also concerns about the potential for side effects, hence the need for safer options using a natural estrogen.
Worldwide contraception product sales in 2005 were $3.6 billion, with projections of approximately $4.5 billion by 2010, as reported by Thomson Pharma®.
An innovative gel formulation that can deliver nestorone in combination with estradiol has been developed using Antares’ advanced transdermal delivery system (ATD™). The gel is invisible, designed for rapid systemic absorption through the skin after application on arms, shoulder or abdomen and lasts for approximately a 24-hour period of time. The formulation is not known to cause irritation or occlusion of the skin after application. All excipients and permeation enhancers used in the formulation are compendial, therefore no specific toxicity studies are required. Development of a contraceptive product at this time builds on the substantial experience gained during Antares’ development of hormone replacement therapy technology and products.
About Antares Pharma
Antares Pharma is a specialized pharma product development company focused on developing patented drug delivery systems and injectable device engineering capabilities. Antares’ current technology platforms include its ATD™ Advanced Transdermal Delivery system, and its related TecTix™ system for topical and transmucosal delivery, its Easy Tec™ oral fast-melt technology, and subcutaneous injection technology platforms including both Vibex™ disposable mini-needle injection device and Valeo™/Vision® reusable needle-free injection devices. Antares Pharma is committed to leveraging its multiple drug delivery platforms to add value to existing drugs and to create new pharmaceutical products and injectable devices. Overall, Antares’ product pipeline, if approved, will address unmet medical needs by reducing side effect profiles, improving safety, increasing effectiveness, and improving patient compliance and convenience. Antares Pharma has corporate headquarters in Princeton Crossroads Corporate Center in Ewing, NJ, with subsidiaries performing research, development, manufacturing and product commercialization activities in Minneapolis, Minnesota and Basel, Switzerland.
About the Population Council
The Population Council is an international, non-profit, non-governmental research organization that 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.
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