FDA CRL - EVOFEM INC

The FDA issued a Complete Response Letter (CRL) to Evofem, Inc. concerning its New Drug Application (NDA 208352) for Amphora vaginal gel, submitted under section 505(b)(2) for pregnancy prevention. The agency could not approve the application due to significant deficiencies in clinical data, manufacturing, and device components.

Clinically, the FDA found Russian study data not generalizable to the U.S. population, and the U.S. data alone provided insufficient evaluable cycles for safety and efficacy. The revised efficacy analysis also failed to meet the pre-specified non-inferiority criterion for preventing pregnancy. Issues with study conduct, such as gel application timing and adverse event reporting, were also noted. Evofem must conduct a new non-inferiority trial, predominantly with U.S. participants, and ensure robust data collection and pre-specified statistical analysis.

A recent inspection of the manufacturing facility revealed deficiencies that require satisfactory resolution. For the device applicators, issues included inconsistent material descriptions, insufficient biocompatibility data (requiring ISO 10993 testing), and concerns with bench testing results for plunger separation forces. Evofem must confirm applicator materials, provide comprehensive biocompatibility testing, and define clear design specifications for applicator forces. All identified issues must be resolved for potential approval.