26 October 2020

The Power Of Choice

  • Adjuvant makes $25 million strategic investment in Evofem Biosciences
  • Evofem’s lead product, Phexxi, is the first and only FDA-approved non-hormonal, non-spermicidal gel for the prevention of pregnancy
  • Proceeds will support the company’s Phase III trial for EVO100, Evofem’s candidate for the prevention of gonorrhea and chlamydia, and expand global market access for Phexxi

Not for injection, ingestion, or any other route

Long is the list of unproven potions, tonics, and elixirs humans have put into our bodies as salves for various real or perceived ailments. A subset of this inclination is the misuse of common household products in ways that fly in the face of intended use and common sense, often touted by prominent social and political figures. Sometimes, corporate marketing efforts laden with not-so-subtle innuendo promote off-label use with limited evidence and disregard for potential harm. Case in point: Lysol for “feminine hygiene”, a euphemism for vaginal cleanliness and contraception that made Lysol one of the most popular contraceptive methods in the 1920s-1950s. Thanks to the Comstock Act of 1873, contraception was classified as “obscene and illicit”, thus douching products could not be explicitly advertised as birth control. Enter the ingenious marketing campaign that not only skirted the Comstock problem, but managed to frame pregnancy prevention as an issue of female hygiene to be addressed in order, for the wife, to avoid marital neglect.

Yikes!

A Brief History of Contraception

Scientists first discovered the existence of the female egg in 1827. Shortly thereafter, in 1843, it was scientifically confirmed that baby making results from sperm not only entering the egg, but combining with it (it was previously thought that sperm alone was the source of life and the egg was merely its site of growth 🙄). Queue the influx of barrier methods seeking to stop said combination: by the 1870s, a variety of birth control devices are available in the US, including condoms, sponges, douches, diaphragms, and cervical caps. A long series of legislative action ensues seeking to criminalize, or at least strictly regulate, contraception.

These restrictions resulted in a collaboration between a few bold doctors and scientists, coupled with funding from philanthropist Katherine McCormick. From their efforts, the first birth control pill (Enovid) was developed in 1956 and approved by the FDA in 1957 for treatment of “severe menstrual disorders” and a drug label warning that Enovid will prevent ovulation. In 1960, the FDA issued approval to sell Enovid as a birth control pill. Thereafter, developments in contraception have largely focused on improvement to the hormonal mixes therein or changes to modality of delivering hormones. Aside from the advent of the copper intra-uterine device (non-hormonal IUD), there has been a severe lack of investment and limited novel product introductions in the 70 years since the approval of Enovid.

Expanding Choice = Empowering Woman

When it comes to contraception, women have historically had to choose among imperfect methods taking into account a number of factors: certainty of protection, side effects, convenience, partner consent, discreetness, impact on pleasure, and duration of effect. Hormonal birth control, while generally deemed more reliable and less prone to user error than barrier methods, can come with a myriad of common side effects including acne, breakthrough bleeding, abnormal menstrual cycles, nausea, headaches / migraines, depression, weight gain, mood swings and decreased libido. Condoms can be used in the heat of the moment without prior consistent adherence, but require partner consent and are commonly thought to decrease pleasure. Long acting hormonal methods like IUDs and implants are convenient, but user concerns around fertility post-removal linger. Importantly, no method aside from condoms protect against sexually transmitted infections (STIs). So, a woman’s choice boils down to what features she values most, and which features she can either tolerate or live without. Given that these tradeoffs are zero-sum, the solution to increasing contraceptive use is to expand the spectrum of choices available to women: enter Phexxi.

Let’s Talk About Phexx[i] Baby

Phexxi, developed by Evofem Biosciences, is a non-hormonal, non-spermicidal vaginal gel designed to foster a vaginal environment inhospitable to sperm and certain STIs. Phexxi is a viscous gel, packaged in a single use tampon-like applicator, that can be administered intravaginally just prior to—or up to an hour before—sex. Phexxi is the first FDA approved contraceptive to offer the following combination of features:

  • non-hormonal
  • discrete and woman-controlled
  • on-demand and short-acting
  • lubrication for increased pleasure

Plus, the potential for STI prevention (Evofem’s EVOGUARD Phase III clinical trial focused on the prevention of chlamydia and gonorrhea is ongoing) is paramount given the increasing annual new case count of chlamydia and gonorrhea globally.

This one-two-punch, coupled with Evofem’s deep commitment to health equity and increasing access to contraceptives for all women, regardless of where they live in the world, is what captured our attention. The potential global health impact of Phexxi is staggering. Of the ~90 million annual unintended pregnancies in developing regions, about 75% can be attributed to contraceptive non-use. Contraceptive non-use is largely driven by discontinuation due to adverse hormonal side effects, fear of sterilization from long term methods, social stigma within communities that oppose family planning, and concerns about partner sentiment. We believe Phexxi is well positioned to address many of these barriers to use.

We are thrilled to partner with Evofem to support the EVOGUARD trial and expand global market access for Phexxi. Evofem is filling a long overdue gap in contraceptive innovation and we could not be prouder to be a small part of the story.