FDA Grants Evofem Biosciences’ Amphora Fast Track Designation

The U.S. Food and Drug Administration (FDA) granted San Diego-based Evofem Biosciences Fast Track designation for Amphora (L-lactic acid, citric acid, and potassium bitartrate) vaginal gel to prevent urogenital chlamydia infection in women.

Evofem Biosciences focuses on developing and marketing products for women’s contraception and protection from sexually transmitted diseases. Amphora is being evaluated to prevent specific sexually transmitted infections (STIs) and potentially as an on-demand, non-hormonal vaginal contraceptive.

“We are pleased that the FDA has recognized the need for a product such as Amphora to prevent this common STI,” said Kelly Culwell, Evofem’s chief medical officer, in a statement. “We look forward to working closely with the FDA to facilitate the development of this preventive therapeutic.”

Amphora is part of an ongoing double-blinded placebo-controlled Phase IIb/III trial in Chlamydia trachomatis infections, which is the primary endpoint, and in Neisseria gonorrhea infections, which is the secondary endpoint. The gel is applied up to one hour before vaginal intercourse. The company expects to enroll about 850 women at up to 20 trial centers in the U.S. Patients are evaluated during an intervention period that lasts four months followed by a one-month follow-up period.

On February 15, Evofem announced it had completed enrollment in the Phase III clinical trial that will evaluate the compound for contraception in about 1,350 women ages 18 through 35 at more than 100 centers across the U.S.

“Our hormone-free, on-demand vaginal gel holds great promise for the prevention of chlamydia and gonorrhea, as well as to prevent pregnancy,” said Saundra Pelletier, Evofem’s chief executive officer, in a statement. “While each of these women’s health issues is important in its own right, Amphora holds even greater promise as a potential combined preventive therapy for all three, which we believe could revolutionize women’s health.”

On January 17, the company closed the previously announced merger with Neothetics. The merged companies will operate as Evofem Biosciences and Saundra Pelletier will act as the chief executive officer. The stock will trade on the Nasdaq Capital Market un the EVFM ticker symbol.

Stockholders of the former Evofem own about 87 percent of the outstanding common stock of the merged company. Neothetics stockholders own about 13 percent. “The completion of the merger and financing provide a strong foundation for Evofem’s growth initiatives and the advancement of Amphora, a much-needed new offering in women’s healthcare,” said Thomas Lynch, Evofem’s chairman, in a statement. “We are now better positioned to capture this growing market opportunity and create value for patients and shareholders with a truly differentiated product.”

Amphora is described as an “on-demand non-hormonal, woman controlled, surfactant-free investigational new drug.” The FDA has designated it a Qualified Infectious Disease Product (QIDP) for two indications—prevention of urogenital gonorrhea and for the reduction of reoccurrence of bacterial vaginosis. This designation is an effort on the part of the FDA to encourage the development of new antibiotics and antibacterials. QIDP is part of the Generating Antibiotics Incentives Now Act (GAIN Act).