FDA grants IND clearance to DARE-VVA1 for dyspareunia | Image Credit: © Postmodern Studio - © Postmodern Studio - stock.adobe.com.
The FDA has cleared an investigational new drug (IND) application for DARE-VVA1, according to Daré Bioscience, Inc.1
- The FDA has granted clearance for an Investigational New Drug (IND) application for DARE-VVA1, a tamoxifen-based therapy developed by Daré Bioscience, Inc.
- DARE-VVA1 is being developed as a non-hormonal therapy for moderate to severe dyspareunia in menopausal patients with vulvar and vaginal atrophy (VVA). The therapy is administered intravaginally.
- Tamoxifen, the active component in DARE-VVA1, is a selective estrogen receptor modulator commonly used to treat breast cancer by acting as an estrogen antagonist in breast tissue.
- DARE-VVA1 may provide an alternative for managing VVA symptoms without increasing risks associated with estrogen therapies, especially in patients with contraindications such as HR+ breast cancer or genetic predisposition to breast cancer.
- Vulvar and vaginal atrophy (VVA) is highlighted as an underdiagnosed condition, with over half of postmenopausal women experiencing it. The FDA clearance for DARE-VVA1 is seen as a significant step in addressing the unmet need for non-hormonal therapies in women with contraindications to estrogen therapies.
The FDA describes an IND as, “a request from a clinical study sponsor to obtain authorization from the FDA to administer an investigational drug or biological product to humans.”2 Study sponsors must receive an IND before interstate shipment and administration for products that have not received an approved New Drug Application or Biologics License Application.
DARE-VVA1 is a tamoxifen currently being developed as a non-hormone therapy to be administered intravaginally in patients with moderate to severe dyspareunia, which often presents in menopausal patients with vulvar and vaginal atrophy (VVA).1 Tamoxifen is aselective estrogen receptor modulator often used to treat breast cancer, acting as an estrogen antagonist in breast tissue.
Estrogen therapies are often contraindicated in HR+ breast cancer patients or those with a genetic predisposition or familial history of breast cancer because of occurrence or recurrence risk. As a tamoxifen therapy, DARE-VVA1 may be able to manage VVA symptoms without increasing the risks of outcomes association with estrogen therapies.
VVA is caused by chronic hypo-estrogenism, determined by decreased levels of circulating estrogen. Symptoms include vaginal dryness, burning, itching, and painful intercourse, also referred to as dyspareunia.
Over half of postmenopausal women experience VVA, negatively impacting quality of life, yet only 56% of these patients discuss their symptoms with a health care professional. This indicates VVA is an underdiagnosed condition.
According to Sabrina Martucci Johnson, president and chief executive officer of Daré Bioscience, there is a large unmet need for non-hormonal therapies to manage VVA symptoms in women with contraindications to estrogen therapies. The IND clearance for DARE-VVA1 marks a step in bringing a potential non-hormonal option to these patients.
- Daré Bioscience announces FDA clearance of investigational new drug (IND) application for DARE-VVA1, a novel intravaginal formulation of tamoxifen for moderate to severe dyspareunia, a symptom of vulvar and vaginal atrophy associated with menopause. Daré Bioscience. December 7, 2023. Accessed December 7, 2023. https://ir.darebioscience.com/news-releases/news-release-details/dare-bioscience-announces-fda-clearance-investigational-new-drug
- Submission of an investigational new drug application (IND) to CBER. US Food and Drug Administration. Accessed December 7, 2023. https://www.fda.gov/vaccines-blood-biologics/investigational-new-drug-applications-inds-cber-regulated-products/submission-investigational-new-drug-application-ind-cber#:~:text=An%20Investigational%20New%20Drug%20Application%20(IND)%20is%20a%20request%20from,or%20biological%20product%20to%20humans