Home / FDA News / FDA Grants Qualified Infectious Disease Product Designation to Daré Bioscience’s DARE-BV1 for Treatment of BV in Women

FDA Grants Qualified Infectious Disease Product Designation to Daré Bioscience’s DARE-BV1 for Treatment of BV in Women

SAN DIEGO, Aug. 12, 2019 (GLOBE NEWSWIRE) — Daré Bioscience, Inc. (NASDAQ:DARE), a leader in women’s health innovation, today announced that DARE-BV1, a novel thermosetting hydrogel containing clindamycin phosphate 2%, has been granted Qualified Infectious Disease Product (QIDP) designation by the U.S. Food and Drug Administration (FDA) for the treatment of bacterial vaginosis (BV) in women.

“Receiving QIDP designation for DARE-BV1 for the treatment of BV is validation that BV is a serious infection for which current treatment options are inadequate.  Our novel thermosetting hydrogel technology delivering clindamycin has the potential to become a powerful new treatment option for health care providers struggling to adequately address and resolve this persistent vaginal infection,” said Sabrina Martucci Johnson, President and CEO of Daré Bioscience. “With clinical cure rates of currently approved products in the range of 37-68% and prevalence of BV in the U.S. estimated to be over 21 million among women ages 14–49, there is significant need for a more effective treatment. We believe the unique thermosetting hydrogel formulation characteristics of DARE-BV1 may result in better antibiotic delivery to the vaginal infection, which can lead to better clinical outcomes.”

In an investigator-initiated proof-of-concept study, DARE-BV1 demonstrated an 86% clinical cure rate in the evaluable subjects at the test-of-cure visit (Day 7-14) after a single administration. Daré intends to commence a Phase 3 clinical study of DARE-BV1 in approximately 250 women in the fourth quarter of 2019. Based on prior discussions with the FDA, Daré believes that the Phase 3 study, if successful, would be sufficient for approval of DARE-BV1 to treat BV.

QIDP designation is available under Title VIII of the Food and Drug Administration Safety and Innovation Act, titled Generating Antibiotic Incentives Now (GAIN), which creates incentives for the development of antibacterial and antifungal drug products that treat serious or life-threatening infections. The primary incentive is a five-year exclusivity extension added to any exclusivity for which a QIDP qualifies upon FDA approval.  Additionally, DARE-BV1’s QIDP designation makes it eligible for Fast Track designation and Priority Review. 

About Bacterial Vaginosis (BV)

BV is the most common vaginal infection in women ages 15-44.1 BV is characterized by a shift in the vaginal flora from the dominant Lactobacillus to a polymicrobial flora.3  BV has been associated with serious health issues, including preterm births, infertility, pelvic inflammatory disease, increased susceptibility to sexual transmitted infections (including HIV infection) and other chronic health problems.1,2

1. Center for Disease Control and Prevention (CDC). www.cdc.gov/std/bv/stats.htm
2. Onderdonk, A. et al. “The Human Microbiome during Bacterial Vaginosis,” Clinical Microbiology Reviews, April 2016 Volume 29 Number 2

About DARE-BV1

DARE-BV1 is a viscous liquid designed to undergo solution to gel (sol-to-gel) transition using body temperature as the trigger. This property allows the product to be more easily directed to the site of infection. Pre-clinical studies demonstrated that, by the process of “reverse thermal gelation,” the viscosity of the base matrix increases up to four-fold upon reaching normal body temperature when compared to its viscosity at room temperature.

DARE-BV1 is formulated with clindamycin phosphate, a potent antibiotic, which has been found to be effective against organisms usually associated with BV such as Bacteroids spp., Peptococcus spp., Gardnerella vaginalis, Mobiluncus spp. and Mycoplasma hominis. Clindamycin, based on the PK-PD approach to dosing, can be classified as a time-dependent antibiotic for which maximizing the exposure time and the amount of drug is recommended. Topical application, safety, and efficacy of vaginally delivered clindamycin phosphate have been widely demonstrated in published literature. Daré plans to leverage the existing data and established safety profile of other products formulated with clindamycin phosphate to utilize the FDA’s 505(b)(2) pathway for approval of DARE-BV1 as a treatment for BV in the U.S.

About Daré Bioscience

Daré Bioscience is a clinical-stage biopharmaceutical company committed to the advancement of innovative products for women’s health. The company’s mission is to identify, develop and bring to market a diverse portfolio of differentiated therapies that expand treatment options, improve outcomes and facilitate convenience for women, primarily in the areas of contraception, vaginal health, sexual health, and fertility.

Daré’s product portfolio includes potential first-in-category candidates in clinical development: Ovaprene®, a non-hormonal, monthly contraceptive intravaginal ring; Sildenafil Cream, 3.6%, a novel cream formulation of sildenafil to treat female sexual arousal disorder utilizing the active ingredient in Viagra®; DARE-BV1, a unique hydrogel formulation of clindamycin phosphate 2% to treat bacterial vaginosis via a single application; and DARE-HRT1, a combination bioidentical estradiol and progesterone intravaginal ring for hormone replacement therapy following menopause. To learn more about Daré’s full portfolio of women’s health product candidates, and mission to deliver differentiated therapies for women, please visit www.darebioscience.com.

Daré may announce material information about its finances, product candidates, clinical trials and other matters using its investor relations website (http://ir.darebioscience.com), SEC filings, press releases, public conference calls and webcasts. Daré uses these channels to communicate with its investors and the public about the company and other company-related matters. The information Daré posts on its investor relations website may be deemed to be material information. Daré encourages investors, the media, and others interested in the company to review the information Daré posts on its investor relations website: www.darebioscience.com.

Check Also

FDA Grants Regenerative Medicine Advanced Therapy Designation to MB-107 Lentiviral Gene Therapy for X-Linked Severe Combined Immunodeficiency

NEW YORK and MEMPHIS, Tenn., Aug. 22, 2019 (GLOBE NEWSWIRE) — Mustang Bio, Inc. (NASDAQ: …