Vyteris, Inc., developer of the first FDA-approved active transdermal patch and a leader in alternative drug delivery technology, announced positive results from a phase II clinical trial evaluating the safety and efficacy of a pulsatile delivery system for the treatment of female infertility, based on the company's smart patch technology.

The phase II trial enrolled 350 women between 18 and 38 years of age with ovulatory dysfunction. The trial assessed the safety and efficacy of three dosage strengths of pulsatile gonadotropin releasing hormone (GnRH) delivered from an iontophoretic patch compared to oral treatment with another leading infertility drug, and placebo. Based on the company's evaluation of the data, the trial met its primary endpoint by demonstrating a statistically significant difference in ovulation rates for the pulsatile GnRH versus placebo over the single, 21-day treatment cycle. Furthermore, among treatment-compliant patients who had at least one progesterone assessment on or after one week of dosing, the pulsatile GnRH achieved ovulation rates similar to the other leading infertility drug, which is considered a first line treatment option for a majority of these patients. The most common adverse event in the trial was skin irritation at the site of administration.

GnRH is a naturally occurring hormone that is currently approved by the US Food and Drug Administration to induce ovulation in patients with hypothalamic amenorrhoea, which is relatively rare and affects three to five percent of the women with ovulatory dysfunction. The present study indicates GnRH may also be used to safely and effectively induce ovulation in patients with other forms of anovulatory infertility, who represent a wider segment of the infertility population. Furthermore, GnRH historically has not been associated with the antiestrogenic side effects observed with the leading oral infertility treatment used in the comparator arm of the study.

The limitation of currently commercially available GnRH-based treatment is its method of delivery, which requires that the patient use an infusion pump over prolonged periods of time. Based on results of this phase II trial, Vyteris' active, transdermal smart patch technology may provide a convenient, non-invasive means of administering pulsatile GnRH.

"The positive outcome of our phase II trial in female infertility represents a significant milestone for Vyteris and a promising development for the women worldwide who suffer from infertility," said Michael Reidy, Ph.D., chief technology officer at Vyteris. "These data underscore the potential of Vyteris' smart patch technology to meet the growing demand for controlled drug delivery in major therapeutic areas."

According to Family Planning International, approximately 10 per cent of all couples worldwide have or have had fertility problems. The World Health Organization estimates that there are approximately 60-80 million cases of infertility around the world. Infertility affects about 7.3 million women and their partners in the US -- about 12 per cent of the reproductive-age population.

Vyteris, Inc. is the maker of the first active, ready-to-use drug delivery patch (LidoSite) to receive marketing clearance from the US Food and Drug Administration (FDA). Vyteris' proprietary active transdermal smart patch technology delivers drugs comfortably through the skin using low-level electrical energy (iontophoresis).