Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
esreboxetine · 3 trials · 2 indications
| Arm | Type | Description |
|---|---|---|
| A | EXPERIMENTAL | - |
| B | EXPERIMENTAL | - |
| Single oral dose of [14C]-esreboxetine | EXPERIMENTAL | - |
| One | EXPERIMENTAL | - |
| Two | PLACEBO_COMPARATOR | - |
| Three | ACTIVE_COMPARATOR | Administration of a single oral dse of 400mg moxifloxacin |
| Name | Type | Description |
|---|---|---|
| Esreboxetine | DRUG | Tablet once daily either placebo, 4mg or 8mg per day. Subjects will be on active treatment for 4 weeks out of a total of 11 weeks in a crossover dosing |
| [14C]-esreboxetine | DRUG | Single oral dose of 6mg esreboxetine in solution containing approximately 100uCi \[14C\]-esreboxetine |
| placebo | DRUG | Once daily administration of placebo for 9 days. Placebo will be administered double blind |
| moxifloxacin | DRUG | Once daily administration of placebo for 8 days followed by open label single oral dose of 400mg moxifloxacin on day 9 |
Inclusion Criteria: * Subjects who have a recognised diagnosis of fibromyalgia, with defined minimum pain criteria. Control subjects must not have a fibromyalgia diagnosis or symptoms and must match fibromyalgia subjects for age, length of education and gender Exclusion Criteria: * Other confound...
| Company | Ticker | Trials | Lead Phase | Drugs |
|---|---|---|---|---|
| Axsome Therapeutics, Inc. | AXSM | 1 | PHASE3 | AXS-14 |
| Grace Therapeutics, Inc. | GRCE | 1 | - | Undisclosed |
Esreboxetine is an investigational small molecule being studied for fibromyalgia. It has been evaluated in clinical trials for its effects on concentration, memory, decision making, and problem solving in patients with fibromyalgia. Esreboxetine is not approved and remains in clinical development.
Esreboxetine is being developed by Pfizer, Inc., which trades on the New York Stock Exchange under the ticker PFE. The company has sponsored clinical trials of esreboxetine in the United States and Belgium.
Esreboxetine has completed Phase 1 and Phase 2 clinical trials. Two Phase 1 studies and one Phase 2 study have been completed. Esreboxetine is investigational and has not been approved by regulatory authorities.
Esreboxetine has been studied in three completed trials. NCT00752505 was a Phase 2 study in fibromyalgia patients assessing effects on cognition. NCT00800956 was a Phase 1 study in healthy males examining absorption, distribution, metabolism, and excretion. NCT00809289 was a Phase 1 thorough QT study in healthy volunteers.
Esreboxetine is a distinct compound from reboxetine. While both are related molecules, esreboxetine is being developed separately by Pfizer for fibromyalgia. Clinical trials of esreboxetine have focused on cognitive effects in fibromyalgia and pharmacokinetic properties in healthy volunteers.