Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
SER120 · 4 trials · 1 indication
Change in mean serum sodium on Day 8, Day 15, Day 22, Week 4, Week 8, Week 12, Week 20, Week 28 and Week 40 compared to Baseline
Change was calculated as the mean number of nocturic episodes per night between baseline and Week 7
Percent of participants achieving at least 50% reduction in nocturic episodes during the last week of treatment compared to baseline
Change was calculated based on the number of mean nocturic episodes per night between baseline through week 12
Percent of participants achieving at least 50% reduction in mean nocturic episode per night during 12 weeks compared to baseline
| Arm | Type | Description |
|---|---|---|
| SER120 (desmopressin) | EXPERIMENTAL | - |
| SER120 | EXPERIMENTAL | - |
| Placebo | PLACEBO_COMPARATOR | - |
| SER120 (750 ng/day) | EXPERIMENTAL | SER120 (750 ng/day) |
| SER120 (1000 ng/day) | EXPERIMENTAL | SER120 (1000 ng/day) |
| SER120 (1500 ng/day) | EXPERIMENTAL | SER120 (1500 ng/day) |
| Name | Type | Description |
|---|---|---|
| SER120 | DRUG | once a day treatment of nocturia |
| Placebo | DRUG | Nasal Spray |
| SER120 (750 ng/day) | DRUG | - |
| SER120 (1000 ng/day) | DRUG | SER120 (1000 ng/day) |
| SER120 (1500 ng/day) | DRUG | - |
Inclusion Criteria: * Patients completed SPC-SER120-DB1-200901 and SPC-SER120-DB2-200902 studies * Willing to provide consent for the study Exclusion Criteria: * Incontinence * Diabetes Insipidus, Diabetes Mellitus * CHF * Renal Insufficiency * Significant medical history which make participation...
SER120 is an investigational small molecule developed for the treatment of nocturia, a condition in which patients wake repeatedly during the night to urinate. It is being studied in adults aged 50 years and older. SER120 is not approved and remains in clinical development.
SER120 is being developed by Avadel Pharmaceuticals plc, which trades on the Nasdaq under the ticker AVDL. Avadel sponsored the clinical program evaluating SER120 in patients with nocturia, including Phase 2 and Phase 3 studies conducted in the United States.
SER120 has completed Phase 3 clinical development for nocturia. Four trials have been completed, including three Phase 3 studies and one Phase 2 study, with no trials currently active. SER120 is investigational and has not been approved by the FDA.
SER120 has been evaluated in four completed trials: NCT01357356, a Phase 2 study of nasal spray formulations; NCT00981682, a Phase 3 long term safety assessment; NCT00937859, a Phase 3 study in patients with nocturia; and NCT00937378, a Phase 3 non-PK study. Combined enrollment was 1,753 patients.
The SER120 trials were randomized, double blind, and placebo controlled, enrolling 1,753 patients with nocturia across four completed studies in the United States. Participants were 50 years of age or older, and both sexes were eligible. The program included one Phase 2 trial and three Phase 3 trials.