psd-502 and Premature-Ejaculation

The Post-University Interdisciplinary Association of Sexology (AIUS) has brought together a panel of experts to develop French recommendations for the management of premature ejaculation.. Systematic review of the literature between 01/1995 and 02/2022. Use of the clinical practice guidelines (CPR) method.. We recommend giving all patients with PE psychosexological counseling, and whenever possible combining pharmacotherapies and sexually-focused cognitive-behavioral therapies, involving the partner in the treatment process. Other sexological approaches could be useful. We recommend the use of dapoxetine as first-line, on-demand oral therapy for primary and acquired PE. We recommend the use of lidocaine 150mg/mL/prilocaine 50mg/mL spray as local treatment for primary PE. We suggest the combination of dapoxetine and lidocaine/prilocaine in patients insufficiently improved by monotherapy. In patients who have not responded to treatments with marketing authorisation, we suggest using an off-label SSRI, preferably paroxetine, in the absence of a contraindication. We recommend treating ED before PE in patients with both symptoms. We do not recommend using α-1 blockers or tramadol in patients with PE. We do not recommend routine posthectomy or penile frenulum surgery for PE.. These recommendations should contribute to improving the management of PE.

Topics: Benzylamines; Ejaculation; Humans; Lidocaine, Prilocaine Drug Combination; Male; Premature Ejaculation; Treatment Outcome

Premature ejaculation (PE) is a common complaint of male sexual dysfunction affecting men and their partners and consequently causing significant personal and interpersonal distress. Increased sensitivity of the glans penis and abnormalities of the afferent-efferent reflex pathway within the ejaculatory process are involved in the occurrence of PE. Drugs that either selectively reduce penile sensitization or modify the afferent-efferent reflex are well established therapeutic options for PE. Fortacin™ is the first topical treatment to be officially approved for the treatment of primary PE in adult men, and is mentioned as an experimental aerosol (as TEMPE) in the current European Association of Urology guidelines. It was approved for use in the European Union and launched in the United Kingdom in November 2016. Fortacin™ is a eutectic-like mixture of lidocaine 150 mg/mL and prilocaine 50 mg/mL that meets the requirements of an ideal treatment for PE because it is fast acting (within 5 minutes), has durable effects, can be easily used "on-demand", and shows minimal side-effects. The metered-dose spray delivery system allows the desensitizing agents to be deposited in a dose-controlled, concentrated film onto the glans penis consequently reducing its sensitivity. This is translated into a delaying of the ejaculatory latency time without adversely affecting the sensation of ejaculation and orgasmic pleasure. The efficacy and safety of Fortacin™ have been proven by means of increased ejaculatory latency, control, and sexual satisfaction in large scale studies demonstrating the significant benefits for both patients and their partners.

Topics: Anesthetics, Local; Humans; Lidocaine, Prilocaine Drug Combination; Premature Ejaculation; Treatment Outcome

PSD502 is a metered-dose spray for premature ejaculation. The two trials aimed to evaluate the safety and pharmacokinetics of PSD502 in healthy Chinese male and female individuals.. Two phase I, randomized, double-blind, placebo-controlled trials were conducted in men (Trial 1) and women (Trial 2). The participants were randomized 3:1 to receive PSD502 (7.5 mg of lidocaine and 2.5 mg of prilocaine per spray) or a placebo. For male individuals, a single dose (three sprays) once daily was applied to the glans penis for 21 days except for nine sprays (three doses) on days 7 and 14, 4 h apart for each dose. For female individuals, two sprays were applied to the vagina and one to the cervix once daily for 7 days. The primary endpoint was safety. Pharmacokinetics analysis was also performed.. Twenty-four male and 24 female individuals were recruited. Treatment-emergent adverse events occurred in 38.9% (7/18) of male individuals and 66.7% (12/18) of female individuals in the PSD502 group, respectively. Both trials reported 50.0% (3/6) treatment-emergent adverse events for the placebo. No grade ≥ 3 treatment-emergent adverse events, serious adverse events, or treatment-emergent adverse events leading to early withdrawal or discontinuation occurred. After consecutive applications, lidocaine and prilocaine cleared rapidly in both trials. Plasma concentrations exhibited high inter-individual variability. The maximum plasma concentrations of active ingredients were far below the anticipated minimum toxic concentrations. The area under the plasma concentration-time curve of metabolites were ≤ 20% of the parent drugs. No clinically significant accumulations were observed in the two trials.. PSD502 was well tolerated and showed low plasma concentrations in healthy Chinese male and female individuals.

Topics: Administration, Topical; Cervix Uteri; Double-Blind Method; East Asian People; Female; Healthy Volunteers; Humans; Lidocaine; Lidocaine, Prilocaine Drug Combination; Male; Penis; Premature Ejaculation; Prilocaine; Vagina

Topical anaesthetics are considered a first-line therapy option in men with premature ejaculation (PE). A cross-sectional retrospective analysis was performed to evaluate the real-life use of the eutectic mixture of prilocaine/lidocaine spray (FORTACIN™) in a cohort of 198 white-European men who had been consecutively and prospectively seen at a single tertiary-referral andrology centre for self-reported PE and naive for previous PE treatments. Descriptive statistics was used to describe the whole cohort and the paired t-test was applied to investigate potential differences throughout a 12-month follow-up (baseline, 1, 3, 6 and 12 months). Overall, mean (SD) age was 37 (6.5) years. Of all, lifelong, acquired and subjective PE were reported in 101 (51%), 59 (29.8%) and 38 (19.2%) patients at baseline, respectively. FORTACIN™ use increased up to 6 months, with 184 (92.9%) and 128 (66.4%) men who had tried and regularly used the compound, respectively. At 12-month follow-up, 53 (26.8%) men reported a regular use of the compound. Mean Premature Ejaculation Diagnostic Tool score significantly decreased at 6 and 12 months compared to baseline (all p < 0.05). Conversely, mean IELT significantly improved at 6-month follow-up compared to baseline (all p ≤ 0.04). Overall, FORTACIN™ emerged to be a safe and effective treatment option in PE patients of various types, with almost one fourth of patients still under treatment after 12 months. Timing and dosing of the drug can deserve to be adjusted according to patient's needs and their sexual ecology.

Topics: Adult; Cross-Sectional Studies; Ejaculation; Female; Humans; Lidocaine; Lidocaine, Prilocaine Drug Combination; Male; Premature Ejaculation; Prilocaine; Retrospective Studies