Vyteris' Phase II clinical trial of pulsatile delivery system met its primary endpoint by demonstrating a difference in ovulation rates for the pulsatile GnRH versus placebo over the single, 21-day treatment cycle.
In the trial, Vyteris has investigated the safety and efficacy of a pulsatile delivery system for the treatment of female infertility, based on the company’s smart patch technology.
The trial evaluated 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.
The result of the trial also suggested that 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 infertility drug, which is considered a first line treatment option for a majority of these patients.
Michael Reidy, chief technology officer at Vyteris, said: “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. These data underscore the potential of Vyteris’ smart patch technology to meet the growing demand for controlled drug delivery in major therapeutic areas.”