- |||||||||| Fortacin (lidocaine/prilocaine spray) / Regent Pacific Group, Recordati
A Validated Patient Reported Outcome for Premature Ejaculation (S404C) - Mar 30, 2023 - Abstract #AUA2023AUA_2552;
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.
- |||||||||| Priligy (dapoxetine) / AbbVie, Fortacin (lidocaine/prilocaine spray) / Regent Pacific Group, Recordati
Journal: An up-to-date overview of the pharmacotherapeutic options for premature ejaculation. (Pubmed Central) - Jul 23, 2022
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.
- |||||||||| Fortacin (lidocaine/prilocaine spray) / Regent Pacific Group, Recordati
Trial completion, Trial completion date: PSD502 in Subjects With Premature Ejaculation (clinicaltrials.gov) - Jul 5, 2022
P2, N=121, Completed,
Physicians should encourage patients to discuss their needs and expectations and grade any improvement of their condition with treatment. Active, not recruiting --> Completed | Trial completion date: Jun 2021 --> Dec 2021
- |||||||||| Fortacin (lidocaine/prilocaine spray) / Regent Pacific Group, Recordati
Clinical, Journal: Real-life use of the eutectic mixture lidocaine/prilocaine spray in men with premature ejaculation. (Pubmed Central) - Apr 27, 2022
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.
- |||||||||| Fortacin (lidocaine/prilocaine spray) / Regent Pacific Group, Recordati
Journal: Prilocaine/lidocaine spray for the treatment of premature ejaculation: a dose- and time-finding study for clinical practice use. (Pubmed Central) - Mar 23, 2022
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.
- |||||||||| Fortacin (lidocaine/prilocaine spray) / Regent Pacific Group, Recordati
Trial completion date, Trial primary completion date: PSD502 in Subjects With Premature Ejaculation (clinicaltrials.gov) - May 21, 2021
P2, N=100, Active, not recruiting,
Based on these data, patients who are prescribed Fortacin™ should stick to this regimen to optimize treatment results. Trial completion date: Jan 2021 --> Jun 2021 | Trial primary completion date: Nov 2020 --> May 2021
- |||||||||| Fortacin (lidocaine/prilocaine spray) / Regent Pacific Group, Recordati
Enrollment closed: PSD502 in Subjects With Premature Ejaculation (clinicaltrials.gov) - Oct 29, 2020
P2, N=100, Active, not recruiting,
Trial completion date: Jan 2021 --> Jun 2021 | Trial primary completion date: Nov 2020 --> May 2021 Recruiting --> Active, not recruiting
- |||||||||| Fortacin (lidocaine/prilocaine spray) / Regent Pacific Group, Recordati
Trial completion date, Trial primary completion date: PSD502 in Subjects With Premature Ejaculation (clinicaltrials.gov) - May 5, 2020
P2, N=100, Recruiting,
Recruiting --> Active, not recruiting Trial completion date: Dec 2019 --> Dec 2020 | Trial primary completion date: Dec 2019 --> Sep 2020
- |||||||||| Fortacin (lidocaine/prilocaine spray) / Regent Pacific Group, Recordati
Enrollment open: PSD502 in Subjects With Premature Ejaculation (clinicaltrials.gov) - Dec 7, 2018
P2, N=100, Recruiting,
Trial completion date: Dec 2019 --> Dec 2020 | Trial primary completion date: Dec 2019 --> Sep 2020 Not yet recruiting --> Recruiting
- |||||||||| Fortacin (lidocaine/prilocaine spray) / Regent Pacific Group, Recordati
Trial completion date, Trial initiation date, Trial primary completion date: PSD502 in Subjects With Premature Ejaculation (clinicaltrials.gov) - Nov 29, 2018
P2, N=100, Not yet recruiting,
Not yet recruiting --> Recruiting Trial completion date: Oct 2019 --> Mar 2020 | Initiation date: Aug 2018 --> Dec 2018 | Trial primary completion date: Oct 2019 --> Mar 2020
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