Daré Bioscience Announces the Publication of a Pharmacokinetics Study of DARE-FRT1

Dare Bioscience (NASDAQ:DARE) has announced the publication of an article “Pharmacokinetics and tolerability of a novel progesterone intravaginal ring in sheep” in the online journal Drug Delivery and Translational Research.

As quoted in the press release:

The goal of the research was to characterize the in vitro release, pharmacokinetics and local tolerability of DARE-FRT1, a novel ethylene-vinyl acetate intravaginal ring (IVR) drug delivery technology delivering progesterone, in drug-naïve ovariectomized female Dorset crossbred sheep.

DARE-FRT1 is being developed as an optimized IVR technology capable of delivering bio-identical progesterone hormone for the prevention of preterm birth (PTB), and for pregnancy maintenance and support as part of an assistive reproductive technology (ART) procedure.  DARE-FRT1 is designed to allow for convenient non-invasive, non-oral administration of bio-identical progesterone over a 14-day period.

“We believe the results of this study are highly encouraging as they further validate the viability of the IVR technology platform for drug delivery,” said David Friend, PhD, co-author of the article and Chief Scientific Officer of Daré Bioscience. “As with our previously reported study of DARE-HRT1, DARE-FRT1 was well tolerated and we look forward to continuing its development into the clinic as a potential first-in-category therapy for preterm birth and fertility.”

The March of Dimes, an organization dedicated to the health and wellbeing of mothers and infants, supports the use of progesterone to reduce the risk of PTB, defined as birth before 37 weeks of completed gestation¹, and the Society for Assisted Reproductive Technology supports the use of progesterone after egg retrieval to support the lining of the uterus.²  According to the Centers for Disease Control and Prevention (CDC), about 10% of women in the U.S. between the ages of 15-44, or 6.1 million women, face difficulty in getting or staying pregnant.³ AMAG Pharmaceuticals, the maker of Makena®, the first and, until 2018, only product approved by the U.S. Food and Drug Administration (FDA) to reduce the risk of PTB, reported 2018 annual revenue in excess of $320 million for Makena and its authorized generic⁴ and, according to the research firm Global Market Insights, the global ART market will surpass $32.5 billion by 2024.⁵

Click here to read the full press release.