psd-502 and Sexual-Dysfunction--Physiological

Current and upcoming treatment options for premature ejaculation (PE) are of global clinical interest. In 2008, the International Society for Sexual Medicine published an evidence-based definition for PE. While there are no US Food and Drug Administration-approved therapies for PE, the American Urological Association 2004 guidelines state the serotonergic antidepressants paroxetine, sertraline, fluoxetine and clomipramine and the topical lidocaine-prilocaine cream are effective treatment options. However, there are limitations associated with their use, which may be overcome by PE-specific therapies currently in development. Two agents that are in advanced stages of clinical development include: (i) dapoxetine, an on-demand short-acting selective serotonin reuptake inhibitor, and (ii) PSD502, a metered-dose aerosol containing lidocaine and prilocaine, also for on-demand treatment. Another on-demand agent in development is tramadol, a weak opioid that is currently approved for treating pain. Coupled with efficient diagnosis, it is hoped that these newer agents will improve the quality of life for patients who suffer from PE.

Topics: Analgesics, Opioid; Anesthetics, Local; Benzylamines; Ejaculation; Humans; Lidocaine; Lidocaine, Prilocaine Drug Combination; Male; Naphthalenes; Phosphodiesterase 5 Inhibitors; Prilocaine; Serotonin Agents; Sexual Dysfunction, Physiological; Tramadol

Premature ejaculation (PE) is the most common male sexual problem worldwide affecting 22-38% of men. It has a significant morbidity both on patients and their partners, causing distress, anxiety and relationship difficulties. The mainstay of treatment is a combined approach using behavioural therapies and non-licensed medication such as topical anaesthetic preparations, selective serotonin re-uptake inhibitors and phosphodiesterase-5 inhibitors. In recent years, there has been a greater emphasis placed on researching novel treatments and exploring the on-demand use of current preparations. This review provides an overview of current accepted treatments and emerging agents for the use in PE.

Topics: Administration, Oral; Administration, Topical; Anesthetics, Combined; Anesthetics, Local; Benzylamines; Ejaculation; Enzyme Inhibitors; Humans; Lidocaine; Lidocaine, Prilocaine Drug Combination; Male; Naphthalenes; Phosphodiesterase 5 Inhibitors; Prilocaine; Selective Serotonin Reuptake Inhibitors; Sexual Dysfunction, Physiological

Premature ejaculation (PE), the most common male sexual dysfunction, impacts the quality of life of not only the affected male but also his partner. Despite its prevalence, there are currently no United States Food and Drug Administration-approved therapies for PE. In 2004, the American Urological Association published treatment guidelines for PE that recommended the serotonergic antidepressants paroxetine, sertraline, clomipramine and fluoxetine, as well as topical lidocaine-prilocaine cream. None of these treatments were developed for PE, and all have limitations associated with their use. Therapies in development may have advantages over the currently available treatments. These include PSD-502, a metered-dose aerosol of lidocaine and prilocaine used as an on-demand local treatment, and dapoxetine, an on-demand short-acting selective serotonin reuptake inhibitor. Together with a recent, evidence-based definition of PE, these novel therapies should improve sexual function and quality of life in men suffering from PE.

Topics: Animals; Benzylamines; Drug Therapy, Combination; Drugs, Investigational; Ejaculation; Evidence-Based Medicine; Humans; Lidocaine; Lidocaine, Prilocaine Drug Combination; Male; Naphthalenes; Prilocaine; Quality of Life; Sexual Dysfunction, Physiological; Treatment Outcome

Topics: Ejaculation; Humans; Lidocaine; Lidocaine, Prilocaine Drug Combination; Male; Prilocaine; Serotonin Receptor Agonists; Sexual Dysfunction, Physiological

PSD502 is a novel aerosolized, lidocaine-prilocaine, spray being developed for the treatment of lifelong premature ejaculation. The clinical profile of PSD502 is described in one of two double-blind, placebo-controlled, phase III studies.. To determine the effect of PSD502 on the Index of Premature Ejaculation (IPE) and intravaginal ejaculatory latency (IELT) of men with lifelong PE.. Men with lifelong PE who documented an IELT ≤ 1 minute with two or more of the first three sexual encounters during a 4-week baseline period were randomized to receive double-blind treatment with PSD502 or placebo for 3 months. Patients completed IPE and Premature Ejaculation Profile questionnaires at entry and monthly visits, and recorded stop-watch timed IELT during each encounter. Safety was assessed by collecting adverse event data and standard safety measures.. Stopwatch timed IELT recordings and a patient-reported outcome questionnaire the IPE were used in this study to determine the effect of PSD502 applied topically 5 minutes before intercourse.. Two hundred fifty-six men with PE were randomized from 38 centers in the U.S., Canada, and Poland. The geometric mean IELT over the 3-month treatment period increased from a baseline of 0.56 minute and 0.53 minute in the PSD502 and placebo group respectively to 2.60 and 0.80 minute. There were significantly greater increases in the scores for the IPE domains of ejaculatory control, sexual satisfaction and distress in the PSD502 group than in the placebo group, with a mean 5.0 point difference between treatments in change from baseline in the IPE domain for ejaculatory control, 4.6 point difference in change from baseline in the IPE domain for sexual satisfaction, and a 2.5 point difference in change from baseline in the IPE domain for distress. This was supported by improvements in all secondary endpoints.. In this study, PSD502 applied topically to the glans penis 5 minutes before intercourse showed significantly improved ejaculatory latency, ejaculatory control, sexual satisfaction and distress and was shown to be well tolerated by patients and partners.

Topics: Administration, Topical; Adolescent; Adult; Aged; Anesthetics, Local; Anxiety; Coitus; Double-Blind Method; Ejaculation; Humans; Lidocaine; Lidocaine, Prilocaine Drug Combination; Male; Middle Aged; Patient Satisfaction; Prilocaine; Sexual Dysfunction, Physiological; Sexual Partners; Surveys and Questionnaires

To determine the effect of PSD502 applied topically 5 min before intercourse on the Index of Premature Ejaculation (IPE) and intravaginal ejaculatory latency time (IELT) of men with lifelong premature ejaculation (PE) defined according to the International Society of Sexual Medicine (ISSM) definition; secondary objectives were to evaluate the safety and tolerability of PSD502 in patients with PE, and their sexual partners.. Men aged >18 years, in stable heterosexual, monogamous relationships, and with lifelong PE diagnosed according to both the Diagnostic and Statistical Manual of Mental Disorders, fourth edition (text revision) criteria and the ISSM definition, consented (together with their partners) to enter the baseline period of the study. Patients who documented an IELT of

Topics: Administration, Topical; Adult; Aged; Anesthetics, Local; Coitus; Double-Blind Method; Drug Combinations; Ejaculation; Europe; Humans; Lidocaine; Lidocaine, Prilocaine Drug Combination; Male; Middle Aged; Patient Satisfaction; Prilocaine; Sexual Dysfunction, Physiological; Surveys and Questionnaires; Time Factors; Treatment Outcome; Young Adult

To compare the efficacy of sildenafil (Viagra) only, sildenafil plus topical anesthetic cream (EMLA), and topical EMLA-cream-only to that of placebo in treating premature ejaculation.. A total of 84 patients were enrolled in this study. The duration of premature ejaculation in the patients ranged from 9 to 60 months (mean 32.5 +/- 14.6). Patients were randomized into four groups. Group 1 consisted of 20 patients who took placebo for 2 months. Groups 2 and 3 consisted of 20 and 22 patients, respectively, and they received 50 mg sildenafil 45 minutes before coitus for 2 months. In addition, patients in group 3 applied topical EMLA cream to the glans penis 15 minutes before coitus. The 22 patients in group 4 used topical EMLA-cream-only. After at least eight sexual attempts, the patients' clinical responses were assessed using the patient self-description method. Effectiveness was described as improvement plus cure.. The effectiveness was 40% in group 1, 55% in group 2, 86.4% in group 3, and 77.3% in group 4. Of the groups, a significant difference was found in the effectiveness of the treatments (Pearson chi-square= 0.00). No significant difference was found between groups 1 and 2 (P = 0.26). Efficacy was more successful in groups 3 and 4 than in the others (P = 0.00). The difference between groups 3 and 4 was not significant (Pearson chi-square = 0.42).. Sildenafil-only was not superior to placebo or combination treatment. Topical EMLA-cream-only had equal effectiveness to that of sildenafil plus topical EMLA treatment. The use of topical EMLA-cream-only seems to be an effective treatment of premature ejaculation.

Topics: Administration, Topical; Adult; Anesthetics, Local; Drug Therapy, Combination; Ejaculation; Humans; Lidocaine; Lidocaine, Prilocaine Drug Combination; Male; Middle Aged; Ointments; Phosphodiesterase Inhibitors; Piperazines; Prilocaine; Purines; Sexual Dysfunction, Physiological; Sildenafil Citrate; Sulfones; Time Factors

Topics: Anesthetics, Local; Antidepressive Agents; Clomipramine; Ejaculation; Fluoxetine; Humans; Lidocaine; Lidocaine, Prilocaine Drug Combination; Male; Paroxetine; Phosphodiesterase Inhibitors; Prilocaine; Sertraline; Sexual Dysfunction, Physiological; Sexual Dysfunctions, Psychological; Treatment Outcome