Frequently Asked Questions
Is LACTIN-V available for sale?
No, LACTIN-V is not available for sale. It is an investigational drug that has not yet been approved by the FDA.
When will LACTIN-V be available for sale?
LACTIN-V will not be available until Phase 3 clinical development is completed and marketing authorization has been granted by the FDA.
Where will I be able to buy LACTIN-V?
LACTIN-V will be a prescription product available at pharmacies.
What is LACTIN-V?
LACTIN-V is a live biotherapeutic product (LBP) containing the live bacterium Lactobacillus crispatus CTV-05, a naturally occurring member of the human vaginal microbiome. LBP is defined by the FDA as a biologic drug that contains live microorganisms for the prevention, treatment, or cure of a disease or condition of human beings, and not a vaccine.
How is LACTIN-V different from a probiotic?
LACTIN-V is an LBP, not a probiotic. LBPs are regulated as biologic drugs by the FDA. To be approved, they must be safe and effective for their intended use, i.e. to treat or prevent a specific disease indication, and manufactured under strict drug standards.
Many probiotics are sold as dietary supplements, which do not require FDA approval before they are marketed. Dietary supplement labels are not allowed to make specific health claims.
How does LACTIN-V work?
The vaginal microbiota is an ecosystem that is generally dominated by several specific Lactobacillus species. Lactobacilli play a crucial role in women’s genitourinary and reproductive health by producing lactic acid and reducing the pH of the vagina. The acidic conditions are primarily responsible for preventing vaginal infections. Women with a diverse vaginal microbiota with depleted lactobacilli (dysbiosis) have a higher vaginal pH and a greater risk of bacterial vaginosis (BV), pelvic inflammatory disease (PID), sexually transmitted infections (STIs), including HIV and HPV, and pregnancy complications such as preterm birth (PTB). Dysbiosis is also associated with inflammation of the female reproductive tract and disruption of the mucosal epithelial barrier. Conversely, women with a Lactobacillus crispatus dominated microbiota have the lowest vaginal pH and lowest risk of BV, STIs, and PTB. They also have the lowest levels of pro-inflammatory mediators and epithelial barrier disruption.