Daré Announces FDA Approval of XACIATO™ (clindamycin phosphate) Vaginal Gel as a Treatment for Bacterial Vaginosis
- Prescribing information supports positioning of XACIATO as a first line option for the treatment of bacterial vaginosis
- This marks the first FDA-approved product in Daré’s portfolio of potential first in category development candidates
- Strategic partnering discussions ongoing; Conference call will be scheduled once a definitive partnership agreement for commercialization of XACIATO in the
U.S.is finalized and executed; U.S.commercial launch expected 2022
“The FDA approval of XACIATO marks a major milestone not only for Daré as a company but, importantly, for the 21 million women impacted by bacterial vaginosis,” said
“Bacterial vaginosis is not a sexually transmitted infection, but rather an overgrowth of bacteria naturally found in the vagina, which upsets the balance of the natural vaginal microbiome and leads to not only distressing symptoms of odor and discharge, but also increases a woman's risk of preterm birth, infertility, and infections. Today, approximately half of the women treated for bacterial vaginosis experience a recurrence within 12 months of treatment. There is a need for more efficacious and convenient treatment options, particularly products with improved clinical outcomes for not only the newly diagnosed women, but, importantly, also for the women who experience multiple episodes of bacterial vaginosis each year,” said
About Bacterial Vaginosis
Bacterial vaginosis is the most common cause of vaginitis worldwide and is estimated to affect approximately 21 million women in
- Clinical Infectious Diseases 2007; 44:213–9; https://doi.org/10.1086/509577
Centers for Disease Control and Prevention Bacterial Vaginosis (BV) Statistics; https://www.cdc.gov/std/bv/stats.htm. Accessed December 7, 2021. The Journal of Infectious Diseases2006; 193:1478–86; https://www.ncbi.nlm.nih.gov/pubmed/16652274
About XACIATOTM (clindamycin phosphate) Vaginal Gel
XACIATO is the trade name for clindamycin phosphate vaginal gel, 2%. XACIATO is a lincosamide antibacterial indicated for the treatment of bacterial vaginosis in female patients 12 years of age and older. XACIATO is a clear, colorless, viscous gel, which contains clindamycin at a concentration of 2% (present as clindamycin phosphate). A single-dose user-filled disposable applicator delivers 5 g of vaginal gel containing 100 mg of clindamycin. The New Drug Application (NDA) for XACIATO was approved by the FDA on
The NDA was supported by positive results from the DARE-BVFREE Phase 3 randomized, multi-center, double-blinded, placebo-controlled clinical trial evaluating XACIATO in women diagnosed with bacterial vaginosis (NCT04370548).
XACIATO received both Qualified Infectious Disease Product (QIDP) and Fast Track designations from the FDA for the treatment of bacterial vaginosis. As a result of the QIDP designation, XACIATO is expected to receive a five-year extension of the three years of market exclusivity available to the product based on the submission of new clinical data that were essential to its approval. Strategic partnering discussions and other activities intended to support a robust market introduction of XACIATO in 2022 in
Please click here for full Prescribing Information.
Important Safety Information
Indication: XACIATO (clindamycin phosphate) vaginal gel is a lincosamide antibacterial indicated for the treatment of bacterial vaginosis in female patients 12 years of age and older.
Dosage and Administration: Administer one applicatorful (5 g of gel containing 100 mg of clindamycin) once intravaginally as a single dose at any time of the day. Not for ophthalmic, dermal, or oral use.
Contraindications: XACIATO is contraindicated in patients with a history of hypersensitivity to clindamycin or lincomycin.
Warnings and Precautions:
- Clostridioides difficile-Associated Diarrhea (CDAD): Discontinue and evaluate if diarrhea occurs
- Use with Polyurethane Condoms: Polyurethane condoms are not recommended during treatment with XACIATO or for 7 days following treatment. During this time period, polyurethane condoms may not be reliable for preventing pregnancy or for protecting against transmission of HIV and other sexually transmitted diseases. Latex or polyisoprene condoms should be used.
Adverse Reactions: The most common adverse reactions reported in >2% of patients in the Phase 3 placebo-controlled trial and at a higher rate in the XACIATO group than in the placebo group were vulvovaginal candidiasis and vulvovaginal discomfort.
Drug Interactions: Systemic clindamycin has neuromuscular blocking properties that may enhance the action of other neuromuscular blocking agents. It should be used with caution in patients receiving such agents.
Use in Specific Populations:
- Other clindamycin vaginal products have been used to treat pregnant women during the second and third trimester. XACIATO has not been studied in pregnant women. However, based on the low systemic absorption of XACIATO following the intravaginal route of administration in nonpregnant women, material use is not likely to result in significant fetal exposure to the drug.
- Similarly, because systemic absorption following intravaginal administration of clindamycin is low, transfer of the drug into breastmilk is likely to be low and adverse effects on the breastfed infant are not expected.
- The safety and effectiveness of XACIATO have not been established in pediatric patients younger than 12 years of age.
To report SUSPECTED ADVERSE REACTIONS, contact Daré Bioscience at 866-XACIATO (866-922-4286) or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.
About Daré Bioscience
Daré Bioscience is a clinical-stage biopharmaceutical company committed to advancing 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 prioritize women's health and well-being, expand treatment options, and improve outcomes, primarily in the areas of contraception, fertility, and vaginal and sexual health.
Daré’s product portfolio includes potential first-in-category candidates in clinical development: Ovaprene®, a novel, hormone-free monthly contraceptive whose U.S. commercial rights are under a license agreement with Bayer; Sildenafil Cream, 3.6%, a novel cream formulation of sildenafil to treat female sexual arousal disorder utilizing the active ingredient in Viagra®; and DARE-HRT1, a combination bio-identical estradiol and progesterone intravaginal ring for hormone therapy following menopause. Daré’s New Drug Application (NDA) for XACIATO (clindamycin phosphate) vaginal gel (formerly known as DARE-BV1) was approved by the FDA on
Daré may announce material information about its finances, product candidates, clinical trials and other matters using the Investors section of its website (http://ir.darebioscience.com), SEC filings, press releases, public conference calls and webcasts. Daré will use these channels to distribute material information about the company, and may also use social media to communicate important information about the company, its finances, product candidates, clinical trials and other matters. The information Daré posts on its investor relations website or through social media channels may be deemed to be material information. Daré encourages investors, the media, and others interested in the company to review the information Daré posts in the Investors section of its website and to follow these Twitter accounts: @SabrinaDareCEO and @DareBioscience. Any updates to the list of social media channels the company may use to communicate information will be posted on the investor relations page of Daré’s website mentioned above.
Daré cautions you that all statements, other than statements of historical facts, contained in this press release, are forward-looking statements. Forward-looking statements, in some cases, can be identified by terms such as “believe,” “may,” “will,” “estimate,” “continue,” “anticipate,” “design,” “intend,” “expect,” “could,” “plan,” “potential,” “predict,” “seek,” “should,” “would,” “contemplate,” “project,” “target,” or the negative version of these words and similar expressions. In this press release, forward-looking statements include, but are not limited to, statements relating to a commercial partnership for XACIATO, the timing of commercial launch of XACIATO in the
Investors on behalf of Daré
Media on behalf of Daré Bioscience, Inc.:
Source: Daré Bioscience, Inc.