title: Late-stage clinical development in lower urogenital targets: sexual dysfunction.
abstract: In recent years, late-stage clinical drug development that primarily focuses on urogenital targets has centered around four areas of medical need (both unmet need and aiming to improve on existing therapies). These include male sexual dysfunction (MSD), female sexual dysfunction (FSD), prostatic pathology (neoplastic, pre-neoplastic, and non-neoplastic), and improvement in lower urinary tract symptoms. Despite the regulatory approval of compounds to treat erectile dysfunction (ED), benign prostatic hyperplasia, a number of treatments for overactive bladder, and stress urinary incontinence, there remains a deficiency in addressing a number of conditions that arise out of pathophysiological dysfunction resulting in lower urogenital tract sexual conditions. In terms of late-stage clinical development, significant progress has most recently been made in MSD development, especially in understanding further a common and complex sexual dysfunction--that of premature ejaculation. The search also continues for compounds that improve ED in terms of better efficacy and superior safety profile compared to the currently marketed phosphodiesterase-5-inhibitors. Whilst there are no approved medications to treat the subtypes of FSD, there has been significant progress in attempting to better understand how to appropriately assess treatment benefit in clinical trial settings for this difficult to diagnose and treat condition. This review will focus on late-stage human clinical development pertaining to MSD and FSD.
authors.affiliation: Johnson & Johnson Pharmaceutical Research & Development, Raritan, NJ 08869, USA. uazam@prdus.inj.com
authors.forename: Usman
authors.initials: U
authors.lastname: Azam
mesh_terms: D000527:Alprostadil / Q000627:therapeutic use; D000728:Androgens / Q000627:therapeutic use; D001596:Benzylamines / Q000494:pharmacology / Q000627:therapeutic use; D002986:Clinical Trials as Topic; D018491:Dopamine Agonists / Q000494:pharmacology / Q000627:therapeutic use; D004542:Ejaculation / Q000187:drug effects; D007172:Erectile Dysfunction / Q000188:drug therapy / Q000378:metabolism; D005260:Female; D006801:Humans; D008297:Male; D009281:Naphthalenes / Q000494:pharmacology / Q000627:therapeutic use; D010726:Phosphodiesterase Inhibitors / Q000627:therapeutic use; D017448:Receptors, Dopamine D2 / Q000819:agonists / Q000378:metabolism; D017367:Selective Serotonin Reuptake Inhibitors / Q000494:pharmacology / Q000627:therapeutic use; D012735:Sexual Dysfunction, Physiological / Q000175:diagnosis / Q000188:drug therapy* / Q000503:physiopathology; D020018:Sexual Dysfunctions, Psychological / Q000175:diagnosis / Q000188:drug therapy*; D011795:Surveys and Questionnaires; D016896:Treatment Outcome; D014665:Vasodilator Agents / Q000627:therapeutic use
chemical_list: D000527:Alprostadil; D000728:Androgens; D001596:Benzylamines; D018491:Dopamine Agonists; D009281:Naphthalenes; D010726:Phosphodiesterase Inhibitors; D017448:Receptors, Dopamine D2; D017367:Selective Serotonin Reuptake Inhibitors; D014665:Vasodilator Agents; C080598:dapoxetine