Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
SER120 750 ng · 2 trials · 1 indication
Change was calculated based on the number of mean nocturic episodes per night between baseline through week 12
Percent of participants with equal of greater than 50% reduction in mean nocturic episodes over the twelve week period
Mean serum sodium reported at baseline, Day 4, Day 8, Day 15, Day 22, Day 29, Day 43 and Day 57.
| Arm | Type | Description |
|---|---|---|
| SER120 750 ng | EXPERIMENTAL | SER120 750 ng |
| SER120 1500 ng | EXPERIMENTAL | SER120 1500 ng |
| Placebo | PLACEBO_COMPARATOR | Placebo |
| SER120 500 ng/day | EXPERIMENTAL | SER120 Level 1 (500 ng/day) |
| SER120 750 ng/day | EXPERIMENTAL | SER120 Level 2 (750 ng/day) |
| Name | Type | Description |
|---|---|---|
| SER120 750 ng | DRUG | SER120 750 ng |
| SER120 1500 ng | DRUG | SER120 1500 ng |
| Placebo | DRUG | Placebo |
| SER120 Nasal Spray 500 ng/day | DRUG | SER120 Level 1 |
| SER120 nasal spray 750 ng/day | DRUG | SER120 (750 ng/day) |
Inclusion Criteria: * Male and female 50 years or older * Nocturia of 6 or more months duration averaging greater than 2 nocturic episodes per night Exclusion Criteria: * CHF * Diabetis Insipidus * Renal insufficiency * Hepatic insufficiency * Incontinence * Illnesses requiring systemic steroids ...
SER120 750 ng is an investigational nasal spray being studied for the treatment of nocturia, a condition in which people wake up one or more times during the night to urinate. It is a small molecule therapy delivered intranasally and is not yet approved for commercial use.
SER120 750 ng is being developed by Avadel Pharmaceuticals plc, which trades on the Nasdaq under the ticker AVDL. Avadel is the sponsor of the clinical program evaluating this nasal spray formulation in patients with nocturia.
SER120 750 ng is in Phase 3 clinical development for nocturia. It has completed two Phase 3 trials, and no trials are currently active. The drug remains investigational and has not been approved by the FDA.
SER120 750 ng has been evaluated in two completed Phase 3 trials: NCT01900704, a multicenter double-blind placebo-controlled study in 810 patients with nocturia, and NCT01259128, a safety and pharmacokinetics study in 32 elderly patients aged 75 and older. Both trials were conducted in the United States.