Fortacin (lidocaine/prilocaine spray) / Regent Pacific Group, Recordati, Orient Europharma, Fosun Pharma - LARVOL DELTA

A Validated Patient Reported Outcome for Premature Ejaculation (AUA 2023) - "In the validation study the active comparator used was PSD502, the metered dose aerosolized eutectic mixture of lidocaine and prilocaine... FDA has been critical of other PROs in so far as the focus has been on "distress" rather than "bother". Under FDA guidance this has been addressed withe the development of the PEBEQ. The data presented show that patients do not necessarily differentiate between distress and bother, in terms of the presenting symptoms of premature ejaculation."

Clinical • Patient reported outcomes • Sexual Disorders

PSD502 in Subjects With Premature Ejaculation (clinicaltrials.gov) - P2 | N=121 | Completed | Sponsor: Plethora Solutions Ltd | Active, not recruiting ➔ Completed | Trial completion date: Jun 2021 ➔ Dec 2021

Trial completion • Trial completion date • Sexual Disorders

Prilocaine/lidocaine spray for the treatment of premature ejaculation: a dose- and time-finding study for clinical practice use. (PubMed, Int J Impot Res) - "Our main study findings showed that the treatment regimen with three sprays of Fortacin™ administered 5 min before sexual intercourse showed the best results in terms of ejaculation time and control (Phase I, IELT 221 ± 3.4, PEDT 7.7 ± 0.3; Phase II, IELT 213 ± 4.9, PEDT 7.8 ± 0.4) with a safety profile that was identical to other treatment regimens. Based on these data, patients who are prescribed Fortacin™ should stick to this regimen to optimize treatment results."

Journal • Sexual Disorders

An up-to-date overview of the pharmacotherapeutic options for premature ejaculation. (PubMed, Expert Opin Pharmacother) - "Currently, only dapoxetine and an anesthetic spray containing lidocaine and prilocaine (Fortacin™) are officially approved, with the rest being used off-label...Adverse events of any therapy should be taken under consideration. Physicians should encourage patients to discuss their needs and expectations and grade any improvement of their condition with treatment."

Journal • Anesthesia • Sexual Disorders

[VIRTUAL] Prilocaine/lidocaine spray to treat premature ejaculation: A dose and timing finding prospective protocol (EAU 2021) - No abstract available

Clinical • Sexual Disorders

PSD502 in Subjects With Premature Ejaculation (clinicaltrials.gov) - P2; N=100; Active, not recruiting; Sponsor: Plethora Solutions Ltd; Trial completion date: Jan 2021 ➔ Jun 2021; Trial primary completion date: Nov 2020 ➔ May 2021

Clinical • Trial completion date • Trial primary completion date • Sexual Disorders

Real-life use of the eutectic mixture lidocaine/prilocaine spray in men with premature ejaculation. (PubMed, Int J Impot Res) - "Topical anaesthetics are considered a first-line therapy option in men with premature ejaculation (PE). 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."

Clinical • Journal • Anesthesia • Sexual Disorders

PSD502 in Subjects With Premature Ejaculation (clinicaltrials.gov) - P2; N=100; Active, not recruiting; Sponsor: Plethora Solutions Ltd; Recruiting ➔ Active, not recruiting

Clinical • Enrollment closed • Sexual Disorders

PSD502 in Subjects With Premature Ejaculation (clinicaltrials.gov) - P2; N=100; Recruiting; Sponsor: Plethora Solutions Ltd; Trial completion date: Dec 2019 ➔ Dec 2020; Trial primary completion date: Dec 2019 ➔ Sep 2020

Clinical • Trial completion date • Trial primary completion date