Dare´ Bioscience, Inc. announced the successful completion of an end-of-Phase 2 (EoP2) meeting with the U.S. Food and Drug Administration, supporting advancement of Sildenafil Cream, 3.6% (Sildenafil Cream) for the treatment of female sexual arousal disorder (FSAD) to a Phase 3 clinical study. The Company also provided an update on focus areas for 2024. Progressing Towards Sildenafil Cream Phase 3 Pivotal Study The Company and the FDA aligned on key elements of the Phase 3 program to support a New Drug Application (NDA) filing, including confirming that: FSAD is acceptable as an indication.

The trials can be conducted in a premenopausal FSAD-only population. 12-weeks of blinded treatment to assess efficacy may be acceptable, provided that the trials are adequately powered for efficacy assessment. This is a shorter period of blinded treatment than the 24 weeks recommended in 2016 draft FDA guidance for developing drugs for the treatment of low sexual interest, desire and/or arousal in women.

Additionally, the FDA indicated that feedback is forthcoming on the following: Primary and secondary patient reported outcome endpoints which will be used in Phase 3 pivotal trials and support potential product registration and labeling. Additional information on data that may be needed in an NDA submission to appropriately qualify any ingredient (other than sildenafil) for the vaginal route of administration. Daré has also requested clarification on the safety database (size and duration of exposure) required for an NDA submission.

The EoP2 meeting was supported by positive data from the exploratory Phase 2b RESPOND clinical study, which assessed arousal sensation and evaluated concerns related to difficulties with sexual arousal over a 12-week double-blinded treatment period. The Phase 2b study results identified the subgroup of patients most likely to benefit from therapy and achieve a meaningful improvement, and in those subjects demonstrated that Sildenafil Cream improved arousal sensation, desire, orgasm, as well as stress, guilt, and embarrassment about the sexual dysfunction. The Phase 2b data are being used to enrich the odds of a successful Phase 3 program.

There are currently no FDA-approved therapies for the treatment of FSAD. FSAD, as described in the DSM-IV, is a condition characterized as primarily by a persistent or recurrent inability to attain or maintain sufficient genital arousal (an adequate lubrication-swelling response) during sexual activity, frequently resulting in distress or interpersonal difficulty, and, of the various types of female sexual dysfunction disorders, FSAD is most analogous to erectile dysfunction in men. As with ED in men, FSAD is associated with insufficient blood flow to the genitalia.

Sildenafil, a phosphodiesterase-5 (PDE-5) inhibitor, is the active ingredient in a tablet for oral administration currently marketed under the brand name Viagra® for the treatment of ED in men. Sildenafil Cream is an investigational, proprietary cream formulation of sildenafil designed for topical administration to the vulvar-vaginal tissue on demand to increase genital blood flow and provide improvements in the female genital arousal response, while avoiding systemic side effects observed with oral formulations of sildenafil. Market research suggests that 16% of women in the U.S. ages 21 to 60, or approximately 10 million women, are distressed from experiencing symptoms associated with FSAD, including lack of or low sexual arousal, and are actively seeking solutions to improve their condition.

In comparison, the prevalence of complete ED in men is estimated to be about 5% of men at age 40, increasing to about 15% at age 70.