This article is more than 5 years old. Information may no longer be current.

FDA designates topical antifungal treatment as QIDP

Add topic to email alerts

Receive an email when new articles are posted on

Please provide your email address to receive an email when new articles are posted on .

Subscribe

Added to email alerts

You've successfully added to your alerts. You will receive an email when new content is published.

Click Here to Manage Email Alerts

You've successfully added to your alerts. You will receive an email when new content is published.

Click Here to Manage Email Alerts

Back to Healio

We were unable to process your request. Please try again later. If you continue to have this issue please contact customerservice@slackinc.com.

Back to Healio

The FDA has designated Cidara Therapeutics’ topical antifungal treatment as a qualified infectious disease product and granted fast track status for its development, the company announced today.

CD101 topical is used for the treatment of vulvovaginal candidiasis (VVC) and the prevention of recurrent VVC infections, the release said. The drug has previously demonstrated broad-spectrum activity against Candida species. It will be further evaluated this year in the RADIANT study — a phase 2 comparative clinical trial.

According to the release, 75% of women worldwide develop VVC in their lifetime, and between 4 million and 5 million women in the United States have recurrent VVC, a mucosal infection. VVC can occur in women of any age, but is particularly common in pregnant women. According to CDC guidelines, pregnant women should only receive topical antifungal products to treat vulvovaginal yeast infections.

Cidara Therapeutics previously received orphan drug designation from the FDA for CD101 IV, an antifungal medication used to treat candidemia and invasive candidiasis fungal infections. Results from a phase 1 multiple ascending dose clinical trial of CD101 IV demonstrated excellent safety and tolerability across a broad range of doses.

Jeffrey Stein

“The QIDP and Fast Track designations for CD101 topical will enable Cidara to speed the development of this compound, which is the first echinocandin antifungal to be developed as a topical treatment,” Jeffrey Stein, PhD, president and chief executive officer of Cidara, said in the release. “Coupled with the earlier QIDP and fast track designations for CD101 IV, we now have the opportunity to expedite the development of CD101 for both systemic and local fungal infections.”

Disclosure: Stein is an employee of Cidara Therapeutics.