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SEXUAL DYSFUNCTION a Dearth of Approved Drugs for Desire and Arousal Disorders Frustrates Women and Clinicians Alike

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SEXUAL DYSFUNCTION a Dearth of Approved Drugs for Desire and Arousal Disorders Frustrates Women and Clinicians Alike UpdatE SEXUAL DYSFUNCTION A dearth of approved drugs for desire and arousal disorders frustrates women and clinicians alike. The good news? Several products are in the pipeline. ›› Barbara S. Levy, MD Dr. Levy is Medical Director of the Women’s Health Center, Franciscan Health System, in Federal Way, Wash. She serves on the OBG Management Board of Editors. Dr. Levy reports no financial relationships relevant to this article. ince sildenafil (Viagra) was approved by tial increases in the risks of coronary artery Sthe US Food and Drug Administration disease and breast cancer. Pivotal trial data to treat erectile dysfunction, women have did not demonstrate enhanced risk, but the In thIs numbers were too small and the timeframe Article been calling for research and development of treatments for female sexual dysfunction. too short (a maximum follow-up of 2 years) Intravaginal DHEA Despite considerable research docu- to establish an effect, so the FDA asked for improves post- menting improvement in sexual responsive- long-term studies. In 2006, European regu- menopausal sexual ness, genital sensation, and overall well-being lators approved Intrinsa to treat low sexual function among women who were given testosterone desire in surgically menopausal women. after undergoing bilateral oophorectomy, Then there’s flibanserin, which also page 25 there remains only one testosterone formula- failed to win approval from an FDA advisory tion for women. A combination of synthetic committee after numerous concerns were What can you offer estrogen and methyl testosterone (Estratest; raised about its safety and efficacy in pre- to patients who report Abbott) is indicated for management of mod- menopausal women (see more about this sexual dysfunction? erate to severe vasomotor symptoms associ- on page 22). page 26 ated with menopause in patients who do not The lack of approved drugs leaves gyne- respond to estrogens alone. cologists and women’s health providers with In the testing stage from BioSante is little to offer our patients who are distressed Dr. Levy talks about LibiGel, a transdermal testosterone prod- by sexual dysfunction. how to talk about sex uct. Acrux is developing Luramist, a daily In this Update, I discuss: with patients testosterone spray. Proctor & Gamble’s • the complexity of female sexual function at obgmanagement.com efforts to gain approval of a testosterone- • what derailed flibanserin containing transdermal patch (Intrinsa) for • recent findings that suggest dehydroepi- treatment of low libido were unsuccessful, androsterone (DHEA) may be beneficial largely because of concern about poten- • recommendations for clinical practice. continued on page 21 20 OBG Management | September 2010 | Vol. 22 No. 9 obgmanagement.com UpdatE sexual dysfunction As understanding of female sexual dysfunction evolves, so do its labels he fourth edition of the Diagnostic and subsumed into a new category, “sexual inter- TStatistical Manual of Mental Disorders est/arousal disorder in women”.1 (DSM-IV) divides female sexual dysfunction into four categories: The female response • hypoactive sexual desire disorder to sexual stimuli is complex (HSDD)—a persistent or recurrent defi- The complexity of sexual arousal disorders in ciency or absence of sexual fantasies and women complicates research into the patho- desire for sexual activity physiology and potential pharmacologic • female sexual arousal disorder—a per- treatment of these conditions. Conflicting sistent or recurrent inability to achieve or evidence for any benefit of the phosphodies- maintain adequate vaginal lubrication or terase type-5 (PDE5) inhibitors, such as silde- vulvar swelling (i.e., sexual excitement) nafil, in the treatment of sexual dysfunction in • female orgasmic disorder—persis- women likely arises from a lack of precision in tent or recurrent delay in or absence of defining the conditions in which and patients orgasm following a normal sexual excite- for whom these interventions are appropriate. ment phase Functional magnetic resonance imaging • dyspareunia—persistent or recurrent (MRI) studies of men and women reveal dif- genital pain that is associated with sexual ferences in areas of brain activity related to intercourse. sexual arousal. The neurophysiology of sex- These categories were revised in 2003 by ual desire and response is complex, involv- an international consensus committee spon- ing multiple neurotransmitters, peptides, In the fifth edition sored by the American Urological Associa- and hormones as well as multiple structural of DSM, hypoactive tion Foundation; arousal disorder has been regions within the brain. Dopamine, nor- sexual desire subdivided into: epinephrine, melanocortin, oxytocin, and disorder and female • combined arousal disorder—absent serotonin (at some of its receptors) promote sexual arousal feelings of sexual arousal from any type of sexual activity, whereas prolactin, gamma disorder may be stimulation, as well as absent or impaired amino butyric acid (GABA), and serotonin subsumed in a new genital sexual arousal (vulvar swelling (at most of its receptors) are inhibitory. category: “Sexual and vaginal lubrication) In animal studies, both an increase in interest/arousal • subjective arousal disorder—absent dopamine and a change in social environ- disorder in women” feelings of sexual excitement and plea- ment can trigger increased sexual behavior. sure from any type of stimulation in the In women, a dopaminergic drug such as presence of genital sexual arousal (vulvar buproprion may increase arousability and swelling and vaginal lubrication) pleasure—but so can a new partner. • genital arousal disorder—subjective All these bits of the “big picture” con- sexual excitement from nongenital sex- tinue to complicate research in female sexual ual stimuli with reduced sensation from function. genital touching and an absence of geni- It is imperative that we begin to under- tal sexual arousal from any type of sexual stand the nuances of our patients’ sexual stimulation. problems if we are to offer effective sugges- These updated definitions will be incorpo- tions for treatment and management. Objec- rated into DSM-V, to be published in 2013. tively determined genital arousal disorder Also likely to change in DSM-V: HSDD very likely derives from neurovascular causes and female sexual arousal disorder may be and is likely to respond to PDE5 inhibitors, obgmanagement.com Vol. 22 No. 9 | September 2010 | OBG Management 21 UpdatE sexual dysfunction but subjective arousal disorder with normal This is the state of our basic science vulvar and vaginal engorgement and lubrica- knowledge in 2010. What’s out there and on tion is not likely to respond to these agents. the horizon for us to offer our patients? Flibanserin gets an unequivocal thumbs down Phase-3 Trial 511.71. A twenty-four week, random- Sexual desire was rated daily by the par- ized, double-blind, placebo-controlled, safety and ef- ticipants using an eDiary. ficacy trial of flibanserin 50 milligrams every evening In North American phase-3 trials, 2,462 and flibanserin 100 mg every evening in women with premenopausal women with acquired HSDD hypoactive sexual desire disorder in North America. in stable, monogamous, functionally hetero- NCT00360529. sexual, communicative relationships for at least 1 year were enrolled. Comorbid arousal Phase-3 Trial 511.75. Best tolerability: 50 mg twice and orgasmic disorders were allowed if they daily versus 100 mg in the evening versus 25 mg twice were secondary to decreased desire. Mean daily versus placebo in younger women in North Amer- age of the participants was 35 to 36 years, ica. NCT00360555. and they were predominantly white, highly educated women in long-term relationships. Two important exclusions worth noting: libanserin is a 5HT 1A agonist, 2A antag- • women who had depression, breast or In phase 2 trials, Fonist, and weak dopamine agonist. It other cancers (except skin cancer), or flibanserin proved was originally studied as a treatment for any major medical condition to be superior major depressive disorder. In phase-2 trials, • women who were taking any of the med- to placebo in it was ineffective for management of depres- ications on a five-page list of excluded improving sex drive sion but superior to placebo and an active drugs (due to metabolism with the in women comparator in improving sex drive (based enzyme cytochrome P3A4). on validated questionnaires). These results Once they were screened, women com- formed the basis for studying flibanserin pleted a 4-week baseline assessment of sex- as a treatment for HSDD. More than 5,000 ual activity and desire, followed by a 24-week women have been involved in phase-2 and study period. They were randomized to phase-3 trials in the United States, Canada, receive 50 mg or 100 mg of flibanserin or pla- and Europe. cebo daily. Improvements in sexual function, Following FDA guidance for spon- compared with the 4-week baseline, had to sors developing treatments for HSDD, drug be both statistically and clinically significant maker Boehringer Ingelheim defined the for the studies to be successful. primary endpoints for the pivotal trials as an increase in the number of sexually satisfying Flibanserin’s effects events (SSEs) and sexual desire, as measured were clinically unimpressive by a daily diary. Sexual events included: At a daily dosage of 100 mg, flibanserin was • genital touching by the partner associated with a significant increase in the • masturbation number of SSEs, compared with placebo.
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