Approval Probability
TA Base Rate
Adjusted LOA
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Dapoxetine · 5 trials · 4 indications
The "Clinical Global Impression of Change" (CGIC), a patient-reported scale was used to assess the patient's improvement with premature ejaculation (PE) since initiating treatment with dapoxetine. Patients were asked: "Compared to the start of the study, would you describe your premature ejaculation (PE) problem as: Much worse, Worse, Slightly worse, No change, Slightly better, Better, or Much better?" The number of patients who described improvement with their PE of at least "slightly better" after 12 weeks of treatment with dapoxetine are provided in the table below.
The intravaginal ejaculatory latency time (IELT) is the time it takes for a man to ejaculate during sexual intercourse (as measured by stopwatch). The data below show the average IELT measured in minutes at Baseline (before treatment) to Endpoint (after 12 weeks of treatment). In this study, patients took placebo or dapoxetine along with a stable dose of a phosphodiesterase-5 inhibitor (PDE5I) prescribed prior to study entry for the treatment of erectile dysfunction.
| Arm | Type | Description |
|---|---|---|
| Dapoxetine | EXPERIMENTAL | Starting dose is one 30-mg tablet taken approximately 1-3 hours prior to sexual activity may be increased after 4 weeks to 60mg taken for 12 weeks. The maximum recommended dosing frequency is once every 24 hours. |
| Dapoxetine + PDE5I | EXPERIMENTAL | Dapoxetine 30 mg to 60 mg tablets 1 to 3 hours before sexual activity prn (as needed) not to be taken more than once every 24 hours for 12 weeks + a PDE5I (phosphodiesterase-5 inhibitor) prescribed prior to study entry for the treatment of erectile dysfunction. |
| Placebo + PDE5I | PLACEBO_COMPARATOR | Placebo tablets identical in appearance to dapoxetine taken 1 to 3 hours before sexual activity prn (as needed) not to be taken more than once every 24 hours for 12 weeks + a PDE5I (phosphodiesterase-5 inhibitor) prescribed prior to study entry for the treatment of erectile dysfunction. |
| Name | Type | Description |
|---|---|---|
| Dapoxetine | DRUG | Starting dose is one 30-mg tablet taken approximately 1-3 hours prior to sexual activity, may be increased after 4 weeks to 60mg, taken for 12 weeks. The maximum recommended dosing frequency is once every 24 hours. |
| Placebo | DRUG | Tablets identical in appearance to dapoxetine taken 1 to 3 hours before sexual activity prn (as needed) not to be taken more than once every 24 hours for 12 weeks. |
| PDE5I (phosphodiesterase-5 inhibitor) | DRUG | Patients were to be using a stable regimen of a PDE5-I (i.e., sildenafil, vardenafil, or tadalafil), as reported by the patient for the treatment of erectile dysfunction (ED) for at least 3 months before screening and up to 12 weeks during treatment in the study. |
Inclusion Criteria: * Participants must be heterosexual males and in a stable monogamous, sexual relationship with a female partner for at least 6 months * must score =11 in the Premature Ejaculation Diagnostic Tool (PEDT) * Must have a self-estimated intravaginal ejaculatory latency time (IELT) of...
Dapoxetine is a small molecule drug developed by Johnson & Johnson (ticker JNJ) for sexual dysfunction, including erectile dysfunction and physiological sexual dysfunction. It is an inhibitor of the serotonin transporter SLC6A4. Dapoxetine is in Phase 3 clinical development and is not approved by the FDA.
Dapoxetine targets SLC6A4, also known as the serotonin transporter. As an inhibitor of SLC6A4, it blocks the reuptake of serotonin, which is thought to modulate ejaculatory function. This mechanism underlies its investigation for sexual dysfunction indications.
Dapoxetine is developed by Johnson & Johnson, which trades under the ticker symbol JNJ. Johnson & Johnson is the sponsor of the clinical trials evaluating Dapoxetine for sexual dysfunction indications.
Dapoxetine is in Phase 3 clinical development. It is an investigational drug and has not been approved by the FDA for any indication. The Phase 3 program includes completed trials in men with sexual dysfunction.
Dapoxetine has been studied in completed Phase 3 trials including NCT01063881, NCT01063855, NCT00229073, and NCT00210704. These trials enrolled men aged 18 years and older with conditions such as erectile dysfunction and physiological sexual dysfunction. All trials are completed and no active trials are ongoing.