Daré Bioscience is committed to accelerating a diverse portfolio of novel therapies for women that expand treatment options, improve outcomes, and facilitate convenience. We are currently advancing a number of innovative candidates through clinical development in the areas of contraception, vaginal health, sexual health, and fertility. If our development efforts are successful, we will seek regulatory approvals and implement commercialization strategies for our products in order to make them available to women worldwide. Our investigational drug candidate for the treatment of bacterial vaginosis (BV), DARE-BV1, is our most advanced candidate and is poised to commence and complete a Phase 3 study in 2020. This Phase 3 study will assess the candidate’s safety and effectiveness and is but one example of the clinical studies that either are underway or are being planned over the next two years.
Expanded Access, also known as Compassionate Use, refers to the use of an investigational product that has not yet been approved by the U.S. Food and Drug Administration (FDA) to treat, diagnose, or prevent a serious disease or condition. Providing an investigational product as part of an Expanded Access Program is a complex matter and is different from studying the investigational product as part of a clinical trial, where more comprehensive safety and efficacy data are collected. We understand the need for Expanded Access Programs under certain circumstances, and we recognize the importance of each clinical trial sponsor thoughtfully considering all the issues and having an appropriate policy in place.
Consistent with the FDA’s and other regulatory agencies’ guidelines regarding when Expanded Access may be appropriate, a number of factors should be considered when developing individual company policies. Those factors include, but are not limited to:
- The illness must be serious or life-threatening with no other satisfactory treatment options (such as approved products or enrolling clinical trials).
- There is sufficient evidence that the potential benefit to the patient would likely outweigh the potential risks, based on available safety and efficacy information on the investigational product.
- The sponsor’s ability to provide a product in a fair and equitable manner, so that there is adequate manufacturing capacity for ongoing clinical programs.
- Whether granting expanded access to certain patients would potentially compromise the scientific validity of broader development programs, or interfere with or delay current clinical trials or regulatory filings designed to make the therapy available to many more patients.
At this time, Daré Bioscience believes that participation in the planned Phase 3 clinical trial is the most appropriate way for women to access this investigational therapy for BV, and therefore neither DARE-BV1 nor any of our other investigational products will be available under Expanded Access Programs. More information about our Phase 3 clinical trial for DARE-BV1, including eligibility criteria, will be posted on clinicaltrials.gov, and the ClinicalTrials.gov Identifier will be provided as soon as the information becomes available. We encourage all eligible patients to speak to their physicians about the possibility of enrolling in our clinical trials in order to gain access to investigational agents and also to support the development of promising new therapies across all medical specialty areas.
Daré Bioscience will be re-evaluating this policy periodically and may revise it at any time. We will continue to push forward our development programs in order to deliver innovative products to the largest number of women as quickly as possible.
If you have any questions about the Daré Bioscience Expanded Access Policy, please contact us at 858-926-7655 or firstname.lastname@example.org.