Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
N1539 · 2 trials · 2 indications
Additionally, to determine the efficacy seen within the first hour after study drug administration, as measured by the SPID 0-60 minutes post-dose.
| Arm | Type | Description |
|---|---|---|
| N1539 5 mg | EXPERIMENTAL | - |
| N1539 7.5 mg | EXPERIMENTAL | - |
| N1539 15 mg | EXPERIMENTAL | - |
| N1539 30 mg | EXPERIMENTAL | - |
| N1539 60 mg | EXPERIMENTAL | - |
| Placebo | PLACEBO_COMPARATOR | - |
| morphine | ACTIVE_COMPARATOR | - |
| Motrin | ACTIVE_COMPARATOR | - |
| Name | Type | Description |
|---|---|---|
| N1539 | DRUG | 5 mg IV once per day |
| placebo | DRUG | IV placebo once per day |
| Morphine | DRUG | morphine 10-15 mg IV once per day |
| Motrin | DRUG | 400 mg |
Inclusion Criteria: * moderate to severe pain with VAS of \>/= 45 mm * undergo open abdominal hysterectomy * ASA I or II * signed ICF * BMI \>18.5 and \< 31.5 kg/m\^2 Exclusion Criteria: * suspected metastatic cervical or endometrial cancer * prior abdominal surgery with postoperative complicatio...
| Company | Ticker | Trials | Lead Phase | Drugs |
|---|---|---|---|---|
| Align Technology, Inc. | ALGN | 2 | N/A | Undisclosed |
| Solventum Corporation | SOLV | 1 | N/A | Undisclosed |
| Haleon PLC Sponsored ADR | HLN | 1 | N/A | Undisclosed |
| DENTSPLY SIRONA, Inc. | XRAY | 1 | N/A | Undisclosed |
| Envista Holdings Corp. | NVST | 2 | - | Undisclosed |
| Smith & Nephew plc Sponsored ADR | SNN | 1 | - | Undisclosed |
N1539 is an investigational small molecule being studied for the treatment of pain, specifically dental pain and pain following hysterectomy. It is being developed by Alkermes plc (NASDAQ: ALKS) and is currently in Phase 2 clinical development.
N1539 is being developed by Alkermes plc, a biopharmaceutical company traded on NASDAQ under the ticker ALKS. The drug is an investigational small molecule in Phase 2 clinical trials for pain indications.
N1539 is in Phase 2 clinical development. It is an investigational drug and has not been approved by regulatory authorities. Two Phase 2 clinical trials studying N1539 have been completed.
N1539 has been studied in two completed Phase 2 clinical trials. NCT00945763 evaluated a single dose of N1539 in 230 patients with dental pain following dental impaction surgery in the United States. NCT01084161 evaluated the efficacy, safety, and tolerability of N1539 in 486 female patients undergoing hysterectomy in Georgia, Poland, and Serbia.
N1539 is a distinct investigational small molecule being developed by Alkermes plc. It is not known to be the same as any other marketed pain medication. Its mechanism of action has not been disclosed.