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 being developed for the treatment of nocturia, a condition characterized by waking at night to urinate. It is administered as a nasal spray and is currently in clinical development, with Phase 3 trials completed.
SER120 is being developed by Avadel Pharmaceuticals plc, a biopharmaceutical company traded on the NASDAQ under the ticker symbol AVDL. The company has conducted multiple clinical trials of SER120 in the United States for the treatment of nocturia.
SER120 has completed Phase 3 clinical trials for the treatment of nocturia. It remains an investigational drug and has not been approved by regulatory authorities. The completed Phase 3 trials include studies evaluating its efficacy and long-term safety.
SER120 has been studied in four completed clinical trials in the United States. These include Phase 3 trials NCT00937378, NCT00937859, and NCT00981682, as well as a Phase 2 trial NCT01357356. The trials enrolled a total of 1,753 patients with nocturia, all aged 50 years and older.
SER120 is a nasal spray formulation being investigated for the treatment of nocturia. Clinical trials have evaluated SER120 nasal spray formulations in patients with nocturia, including a multicenter study (NCT01357356) that enrolled 750 patients.