The company announced that it and the US Food and Drug Administration have reached an alignment for its Phase 2b study design of Sildenafil.
Dare Bioscience (NASDAQ:DARE) has announced that it and the US Food and Drug Administration have reached an agreement on the patient reported outcome (PRO) instruments to be used in a Phase 2b clinical study of Sildenafil cream.
As quoted in the press release:
The discussions with the FDA followed the completion of a content validity study of the proposed PRO instruments, a non-interventional study integral to initiating the at-home, product dosing portion of the Sildenafil Cream Phase 2b program.
“We made excellent progress this year achieving alignment with the FDA on an appropriate and acceptable development plan for a drug to treat FSAD,” said Sabrina Martucci Johnson, President and CEO of Daré Bioscience. “Importantly, we aligned with the FDA on the design of our Phase 2b study, including the PRO instruments to be used to measure achievement of the primary efficacy endpoints, namely improvement in localized genital sensations of arousal and reduction in the distress that women with FSAD experience. We are pleased that the FDA recognizes the validity of the PRO instruments to test the efficacy of a drug to treat FSAD that are specific to the Sildenafil Cream mechanism of action. This is a significant milestone in the development of what has the potential to be the first FDA-approved product to treat FSAD. In addition, we aligned with the FDA on several exploratory efficacy endpoints which will be measured in our Phase 2b study and could potentially prove to be additional measurements of efficacy in a future Phase 3 program. We are encouraged by the continued collaborative approach we are experiencing with all FDA divisions and are thrilled to have reached this point in the Sildenafil Cream development program.”
Of the various types of female sexual dysfunction disorders, FSAD is most analogous to erectile dysfunction (ED) in men and is characterized primarily by an inability to attain or maintain sufficient genital arousal during sexual activity that causes distress or interpersonal difficulty. Despite several approved prescription products for ED, no pharmacologic options have yet been approved by the FDA for FSAD. Sildenafil, the active ingredient in Sildenafil Cream, is marketed in an oral dosage form under the brand name Viagra® for the treatment of ED in men.