Ovaprene™



Ovaprene™ is designed to provide multiple weeks of contraceptive protection without the use of hormones.

OVERVIEW

Ovaprene™ is a clinical stage, non-hormonal contraceptive ring intended to provide protection over multiple weeks of use, require no intervention at the time of intercourse, and fill a void in today’s contraception method mix. It represents a new approach to contraception and if approved, will represent a new birth control category.

HOW IT WORKS

Ovaprene™ is designed to provide multiple weeks of contraceptive protection without the use of hormones.

Ovaprene™ has a custom intravaginal ring design, with a permeable mesh in the center a small silicone ring that creates a partial barrier to sperm, and a mechanism to release locally acting spermiostatic agents through the ring. The silicone ring releases ingredients – ascorbic acid and ferrous gluconate – which act together to create a spermiostatic environment. The non-braided multi-filament mesh component functions as a physical barrier to sperm. The unique combination of these two complementary approaches seeks to produce attractive contraceptive efficacy outcomes that are consistent with the most effective barrier option, the diaphragm, and short-acting hormonal options (pill, patches and vaginal ring) that provide 88-91% effectiveness in “typical use”.

WHO MIGHT BENEFIT

Today, there is a need for a safe non-hormonal contraceptive method that does not require action at the time of intercourse and that provides a level of “typical use” contraception effectiveness approaching that of hormones. The most popular short-acting non-hormonal contraceptive options include condoms and spermicides, methods that lack convenience and have modest “typical use” efficacy ranging from 72-82%.

We believe that a non-hormonal monthly contraceptive ring that is convenient (inserted and worn for multiple weeks), safe and demonstrates typical use effectiveness comparable to diaphragms, pills, patches and hormonal rings (which have 88-91% contraceptive effectiveness in “typical use”) has the potential to capture market share across the broad spectrum of short-acting methods, primarily from non-hormonal contraceptive users and current non-users of any form of contraception, but also from a small segment of hormonal contraceptive users.

Women value convenience and safety. Most women would prefer a contraceptive method they don’t need to remember to take every day and that does not require action at the time of intercourse. A contraceptive ring, whose monthly use is initiated and controlled by a woman, has numerous attributes that women find appealing:

  • An estimated 67% of women said that a monthly vaginal ring has most of the features they deemed extremely important.
  • Nearly 85% would prefer a monthly option with a lower hormone dose than the oral birth control pill.
  • An estimated 80% of women currently use a non-coital dependent method.

Development Phase

Encouraging results to date

In a pilot clinical study conducted in 21 women, Ovaprene™ demonstrated the ability to immobilize sperm and prevent their progression into the cervical mucus. The study also demonstrated the acceptability of the device to both partners. No serious adverse events were reported. (Journal of Reproductive Medicine 2009; 54:685–690)


Ongoing Clinical Development

The FDA previously determined that the division to lead the review of Ovaprene™ will be the Center for Devices and Radiological Health (CDRH ) and that Premarket Approval, or PMA, from the FDA will be necessary to market Ovaprene™ in the United States. We believe the clinical development plan for Ovaprene™ will be guided by the size, structure and results of other barrier contraceptive devices using active agents that obtained approval from CDRH. We believe those other product development plans leading to FDA approvals provide a good indication of the FDA requirements likely to be required for Ovaprene™. Specifically, in addition to demonstrating biocompatibility and safety, we expect the clinical requirements for FDA approval for Ovaprene™ to be:

  • obtaining safety and preliminary efficacy data in a postcoital test (“PCT”) clinical trial, and
  • conducting one large, single arm safety and efficacy study, the pivotal clinical trial.

PCT Clinical Trial

We intend to conduct the PCT clinical trial for Ovaprene™ in collaboration with a leading organization in contraceptive research, CONRAD, which was established in 1986 under a cooperative agreement between Eastern Virginia Medical School and the U.S. Agency for International Development (USAID). CONRAD has conducted PCT studies on numerous currently FDA approved barrier methods of contraception, and conducted the PCT and pivotal trials for the Caya® diaphragm, the most recent barrier contraceptive to receive approval through CDRH. Contraceptive PCTs are generally conducted in 15-30 subjects.

Pivotal Clinical Trial

Assuming positive results from our planned PCT clinical trial of Ovaprene™, our intention is to conduct a pivotal contraceptive efficacy clinical trial of similar size and duration as Caya®. Caya®’s contraceptive pivotal study evaluated pregnancy rates in approximately 250 women over a period of six months.

Prior to the completion of the U.S. pivotal study of Ovaprene™, we may seek a CE Mark approval for Europe using a subset of the total pivotal clinical trial population. The receipt of E.U. or U.S. regulatory approvals can be used to support registration in many other countries around the world.