(497) Is Drug Development for Female Sexual Dysfunction Dead?

Abstract

Abstract Introduction Various agents have been tested to treat female sexual dysfunction (FSD), particularly Hypoactive Sexual Desire Disorder and Female Sexual Arousal Disorder, but only two, flibanserin and bremelanotide, have met any regulatory standards (US only), and none is popular with patients or prescribers. Several more agents, e.g., sildenafil, testosterone, alprostadil, buspirone, bupropion and trazodone, have shown early promise but have not been developed further. Objective Evaluate whether drug development for FSD at a standstill and identify related factors. Methods Selective literature review using the largest, most high-quality surveys available on factors relating to the proportion of women likely to be treated for FSD and of the factors relating to convenience of the posology and the safety of agents for FSD. Results Surveys show that about 40% of women have sexual dysfunction, but lack of related distress and complicating factors decrease the proportion of women likely to be treated medically for primary FSD to about 0.1%. Such complicating factors include antidepressant use and chronic medical illness that prevent diagnosing primary FSD, lack of awareness, and prescriber reluctance. The posology of the available agents and their side effects may limit benefits and thus acceptance, also. Fear of regulatory rejection amid shifting standards for evaluation of efficacy and diagnostic criteria is an intangible but likely factor stalling drug development for FSD, too. Conclusions Major investment in developing medications for FSD may well have ended. The proportion of women with primary (stand-alone) FSD likely to be treated medically is limited to no more than 0.1% of the population because of low awareness of the diagnosis, lack of willingness to be treated, and lack of prescriber knowledge and willingness to diagnose and prescribe. Benign medications for primary FSD are not available with sufficiently robust efficacy and convenience to break down the barriers of patient and practitioner reluctance toward medical treatment. The lack of marketing success with current agents and the fear of surmounting regulatory hurdles probably have had additional chilling influences on drug development in this field. Developing agents for secondary FSD (FSD comorbid with common chronic medical conditions), e.g., HSDD and/or FSAD in women with the genitourinary syndrome of menopause, diabetes, cancer, depression, and antidepressant users, could help far more women, perhaps 10% of the female population. However, such patients should be expected to be more difficult to treat, might well require multimodal approaches using the biopsychosocial model of FSD. A combination of medication with targeted psychotherapy, couples’ therapy, and/or a mindfulness-based intervention might be necessary. Disclosure Any of the authors act as a consultant, employee or shareholder of an industry for: S1 Biopharma, Sprout Pharma, Gedeon Richter.