(319) Evaluating the Racial Distribution of Clinical Trial Participants for Drugs Leading to FDA Approval of Novel Biologics for the Treatment of Hypoactive Sexual Desire Disorder (HSDD)

Abstract

Abstract Introduction Hypoactive sexual desire disorder (HSDD) is defined as a persistent deficiency or absence of sexual desire or sexual fantasies that result in significant personal distress and relationship difficulties. It is considered one of the most prevalent diseases impacting the sexual function of women. Prior studies suggest that the prevalence of HSDD ranges between 8%-20%. Recently, two novel drugs gained FDA approval for the treatment of HSDD. This includes both Addyi and Vyleesi. Although multiple reports suggest that HSDD is more prevalent in white women, HSDD still impacts minority women. Objective Our study aim was to determine the distribution of race and ethnicity among trial participants leading to FDA approval of novel drugs for HSDD. Methods A retrospective review of FDA Center for Drug Evaluation and Research Drug Trials Snapshot (DTS) was conducted utilizing the DTS FDA website (https://www.fda.gov/drugs/drug-approvals-and-databases/drug-trials-snapshots). The DTS highlights who participated in the clinical trials that supported the FDA approval of a drug that is novel. This includes new molecular entities or original biologic products. DTS was searched for drugs created for the treatment of HSDD and clinical trial enrollment data was stratified by race and ethnicity. Results A total of 2 clinical trials were identified that led to the FDA approval of 2 novel drugs for HSDD including Addyi (flibanserin) and Vyleesi (bremelanotide injection) Trials for Addyi included 2743 participants of which 89% were white, 8% Black, 1% Asian, 8% Hispanic, <1% American Indian/Alaska Native, <1% Native Hawaiian/Pacific Islander, 2% unknown. Trials for Vyleesi approval had 1067 participants of which 86% were white, 12% Black, 1% Asian, 8.5% Hispanic, <1% American Indian/Alaska Native, 1% unknown. Limitations include the unknown race category which included both not reported, multiracial, and true unknowns in some trials. Conclusions Participants in clinical trials leading to FDA approval of novel drugs for HSDD are overwhelmingly white in spite of the fact that other women including minorities are impacted by this disorder. Although white women are more likely to report low sexual desire, studies likely underestimate the the impact on minority women. Involving stakeholders who represent the needs and interests of underrepresented populations in the design and implementation of clinical trials of novel agents may be a strategy to increase diversity, equity, and inclusion among drugs designed to impact low sexual desire and treatment of HSDD. Disclosure No.