Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
SER120 750 ng · 1 trial · 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
| Arm | Type | Description |
|---|---|---|
| SER120 750 ng | EXPERIMENTAL | SER120 750 ng |
| SER120 1500 ng | EXPERIMENTAL | SER120 1500 ng |
| Placebo | PLACEBO_COMPARATOR | Placebo |
| Name | Type | Description |
|---|---|---|
| SER120 750 ng | DRUG | SER120 750 ng |
| SER120 1500 ng | DRUG | SER120 1500 ng |
| Placebo | DRUG | Placebo |
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 small molecule being developed for the treatment of nocturia, a condition characterized by waking at night to urinate. It is a nasal spray formulation being studied in patients with nocturia.
SER120 750 ng is being developed by Avadel Pharmaceuticals plc, a biopharmaceutical company traded on the NASDAQ under the ticker symbol AVDL.
SER120 750 ng is in Phase 3 clinical development. It is an investigational drug and has not been approved by regulatory authorities. A Phase 3 trial has been completed to evaluate its safety and efficacy in patients with nocturia.
SER120 750 ng has been studied in a Phase 3 clinical trial with the identifier NCT01900704. This was a multicenter, randomized, double-blind, placebo-controlled study that enrolled 810 patients with nocturia in the United States. The trial has been completed.
SER120 750 ng is a formulation of the drug being studied in the clinical trial titled 'Multicenter Study to Investigate SER120 Nasal Spray Formulations in Patients With Nocturia - DB4'. The trial is referred to as DB4, but SER120 750 ng is the specific drug product being investigated.