Evofem Biosciences Announces FDA Approval of Phexxi for On-Demand Birth Control

Strategic Insights -

Evofem Biosciences, a commercial-stage biopharmaceutical company, has announced the FDA approval of Phexxi, a non-hormonal, on-demand vaginal pH regulator contraceptive. Phexxi is the first of its kind, designed to maintain vaginal pH within the normal range of 3.5 to 4.5, creating an acidic environment that is inhospitable to sperm. This breakthrough product offers women control over their reproductive health without the use of hormones.

Phexxi is indicated for the prevention of pregnancy in females of reproductive potential for use as an on-demand method of contraception. According to Michael A. Thomas, M.D., Chair of the Department of Obstetrics and Gynecology at the University of Cincinnati College of Medicine, "Phexxi represents an important step forward in women's health." Many patients have cycled through numerous contraceptive options and still have not found the right fit for their sexual and reproductive needs.

Key Takeaways:

  • Phexxi is the first non-hormonal, on-demand vaginal pH regulator contraceptive, approved by the FDA for the prevention of pregnancy.
  • The product maintains vaginal pH within the normal range of 3.5 to 4.5, creating an acidic environment that is inhospitable to sperm.
  • Phexxi is designed for women to control their reproductive health without the use of hormones.
  • According to Dr. Michael A. Thomas, Phexxi offers women freedom from hormones and control over how they choose to prevent pregnancy.
  • The Company expects to launch Phexxi in early September alongside the Phexxi Concierge Experience, a comprehensive patient and healthcare provider telemedicine support system.
  • Evofem Biosciences is committed to ensuring access to Phexxi for all women seeking non-hormonal contraception and will provide a financial assistance program to enable access for eligible women.

Statistics:

  • 3.5 to 4.5: The normal range of vaginal pH maintained by Phexxi.
  • 0.36%: The rate of adverse reactions of cystitis, pyelonephritis, and other upper urinary tract infections reported in Phexxi clinical studies.
  • 15-year: The length of Lisa Rarick, M.D.'s, career at the FDA, including participation in the review and approval of many sexual and reproductive health products.

Sources:

  • Evofem Biosciences. (2020, May 22). Evofem Biosciences Announces FDA Approval of Phexxi for On-Demand Birth Control [Press Release].
  • Evofem Biosciences. (n.d.). About Phexxi [Phexxi.com].
  • Evofem Biosciences. (n.d.). About Evofem Biosciences [evofem.com].