FDA Lifts Clinical Hold on Vaginal Yeast Infection Drug Brexafemme After 19 Months

The U.S. Food and Drug Administration (FDA) has lifted its 19-month clinical hold on the vaginal yeast infection drug Brexafemme (ibrexafungerp), according to the treatment's developer Scynexis. This development marks a significant milestone for the company and its partner GSK, potentially revitalizing the drug's commercial prospects.

Clinical Hold Lifted, But Challenges Remain

Scynexis revealed in its first-quarter report that the FDA lifted the suspension late last month. The clinical hold, imposed in September 2023, was prompted by a voluntary recall of Brexafemme tablets due to potential cross-contamination concerns. The issue arose when GSK, which had entered a licensing deal with Scynexis in early 2023, discovered that the equipment used to produce Brexafemme was also used to manufacture a beta-lactam substance, raising concerns about possible allergic reactions in some individuals.

Despite this positive development, challenges persist. GSK has expressed its intention to terminate the delayed study, although Scynexis disputes GSK's right to do so unilaterally under their license agreement. David Angulo, M.D., Scynexis' CEO, stated, "The lifting of the clinical hold for ibrexafungerp was an important achievement for our company." He added that Scynexis is "moving forward" with the MARIO trial, which is investigating Brexafemme as a treatment for invasive candidiasis, with plans to enroll subjects in the "coming weeks."

Commercial Landscape and Future Prospects

Brexafemme, approved in 2021 for vulvovaginal candidiasis (VVC), represented a new class of antifungal drugs in an indication with limited treatment options. Initially projected to have blockbuster potential, the drug faced commercial challenges, leading Scynexis to cut 40% of its staff in 2022 after reporting sales of just $5 million for that year.

The licensing deal with GSK in March 2023, which included $90 million upfront and up to $503 million in potential milestone payments, provided a crucial lifeline for Scynexis. However, GSK later amended the deal, reducing the potential milestone payments.

A GSK spokesperson emphasized the ongoing collaboration, stating, "We continue to work with Scynexis to commercialize Brexafemme. With rates of resistance to other antifungal treatments rising, Brexafemme addresses a clear unmet need for new oral treatments and is an important asset of our growing anti-infectives portfolio."

As Scynexis and GSK navigate the path forward for Brexafemme, the lifting of the FDA's clinical hold represents a critical step in realizing the drug's potential in addressing the growing challenge of antifungal resistance.