A Small Biotech Takes On Some Big Clinical Trial Challenges

By Ed Miseta, Chief Editor, Clinical Leader

Evofem Biosciences is on the cusp of releasing a revolutionary birth control product. But before the FDA gives its approval, this small biopharma has to navigate two very different clinical trials.

Evofem Biosciences’ Amphora is being positioned as the first and only woman-controlled “only when she needs it” birth control product with no hormones and no systemic side effects. “We believe it could be the first birth control product approved by the FDA that also would work to prevent recurrent chlamydia,” explains CEO Saundra Pelletier. Of course, receiving FDA approval for any type of pharmaceutical is daunting, but it could be especially challenging for this type of treatment, known as a Multipurpose Vaginal pH Regulator (MVP-R).