FDA Approves Evofem’s “On-Demand” Non-Hormonal Birth Control Gel

Xconomy National — 

While treatments for many health conditions have undergone reinvention in the past two decades, birth control options haven’t changed much. On Friday, San Diego-based Evofem Biosciences said it received FDA approval for a new kind of contraceptive: a non-hormonal vaginal gel intended for use directly before intercourse.

The drug, a combination of lactic acid, citric acid, and potassium bitartrate (Phexxi, formerly named Amphora), is designed to keep vaginal pH within its typical range. That regulation is intended to maintain a pH level 3.5 to 4.5 on the 0 to 14 scale used to measure acidity or alkalinity, which typically is raised to 7 to 8 in the presence of semen. Keeping the environment acidic makes it inhospitable to sperm, preventing conception.

The product, to be sold in packs of prefilled single-dose applicators, was OK’d for use for pregnancy prevention when administered up to one hour prior to intercourse.

Evofem’s stock price closed Friday at $4.99, up 33 percent compared to the day prior. The FDA nod is the company’s first.

CEO Saundra Pelletier says the Evofem (NASDAQ: EVFM) product stands out among today’s birth control options because it doesn’t use synthetic hormones to prevent pregnancy, is only used when needed, and doesn’t require a sexual partner’s buy-in.

Most types of birth control require regular use or, in the case of injections and implants, a relatively long-term commitment, regardless of the user’s frequency of sexual activity. And the most popular options, including oral contraceptives, deploy synthetic hormones to prevent pregnancy. These chemical messengers, which travel throughout the body, come with health risks, and for some users, unpleasant side effects. Furthermore, unlike condoms—perhaps the most popular “on-demand” method of birth control in use today—Phexxi is, as the company terms, “woman-controlled.”

The FDA approved the drug based on data from a Phase 3 clinical trial enrolling 1,330 women. Data from patients who used the gel over seven menstrual cycles revealed an efficacy rate of 86.3 percent for typical use, which exceeded the trial’s main goal. (According to the Centers for Disease Control and Prevention, oral contraceptives have an efficacy rate of about 91 percent over one year of typical use; condoms, about 82 percent.)

Evofem is also evaluating the drug for its ability to prevent women from contracting two sexually transmitted infections, chlamydia and gonorrhea.

In clinical trials the drug was well tolerated by patients. The most common side effects were burning and itching sensations. The drug’s label advises against its use in patients who have a history of recurrent urinary tract infection or urinary tract abnormalities.

Evofem says it plans to launch the drug, along with a telemedicine platform to facilitate access, in September. The company says it is working toward getting the product covered under the Affordable Care Act.

Since Monday is a federal holiday, the company plans to hold a conference call at 8:30 a.m. ET Tuesday to discuss the approval.

Read more about Evofem and its history here and here.