Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Revefenacin · 3 trials · 4 indications
An adverse event (AE) was any untoward medical occurrence in a participant administered a pharmaceutical product that did not necessarily have to have a causal relationship with this treatment. A treatment-emergent AE is an AE that occurred after the participant has received the study drug.
A serious adverse event (SAE) was defined as any untoward medical occurrence occurring at any dose that resulted in any of the following outcomes: * Death * Life-threatening situation. "Life-threatening" refers to a situation in which the participant was at risk of death at the time of the event; it does not refer to an event which might have caused death if it were more severe * Inpatient hospitalization or prolongation of existing hospitalization * Congenital anomaly in the offspring of a participant who received study drug * Important medical events that may not result in death, be immediately life-threatening, or require hospitalization, could have been considered an SAE when, based upon appropriate medical judgment, they may have jeopardized the participant and may have required medical or surgical intervention to prevent one of the outcomes listed in this definition A treatment-emergent SAE is an SAE that occurred after the participant has received the study drug.
Clinically significant changes identified based on change from baseline. Vital signs measured included heart rate, systolic blood pressure and diastolic blood pressure.
Clinically relevant changes identified based on change from baseline. Laboratory Measures assessed included hematology and serum.
Clinically relevant changes identified based on change from baseline.
FEV1 = forced expiratory volume at one second
The maximum concentration (CPEAK)
| Arm | Type | Description |
|---|---|---|
| Period 1: Revefenacin + Formoterol (Sequential) | EXPERIMENTAL | Days 1 to 21: Revefenacin and formoterol will be sequentially administered in the morning. Formoterol will be administered again in the evening. |
| Period 2: Revefenacin + Formoterol (Combo Solution) | EXPERIMENTAL | Days 22 to 42: After a 21 day period, the participants from the Revefenacin + Formoterol (Sequential) Arm will be dosed for 21 days with a combination of revefenacin and formoterol administered as a combined solution. Formoterol will be administered again in the evening. |
| Period 1: Placebo + Formoterol (Sequential) | PLACEBO_COMPARATOR | Days 1 to 21: Placebo versions of revefenacin and formoterol will be sequentially administered in the morning. Formoterol will be administered again in the evening. |
| Period 2: Placebo + Formoterol (Combo Solution) | PLACEBO_COMPARATOR | Days 22 to 42: After a 21 day period, the participants from Placebo + Formoterol (Sequential) Arm the will be dosed for 21 days with a combination of placebo revefenacin and formoterol administered as a combined solution. Formoterol will be administered again in the evening. |
| Revefenacin | EXPERIMENTAL | Active Revefenacin and placebo (in place of Spiriva Handihaler®) |
| Spiriva Handihaler® | ACTIVE_COMPARATOR | Active Spiriva Handihaler® and placebo (in place of Revefenacin) |
| Revefenacin Inhalation Solution, 175 mcg/3 mL | EXPERIMENTAL | - |
| Name | Type | Description |
|---|---|---|
| Revefenacin | DRUG | Revefenacin is administered via a nebulizer. |
| Placebo | DRUG | Placebo version of Revefenacin is administered via a nebulizer. |
| Formoterol | DRUG | Administered sequentially in both revefenacin and placebo arms using a nebulizer. |
| Spiriva Handihaler® | COMBINATION_PRODUCT | Spiriva Handihaler® contains Spiriva (also known as Tiotropium) and is administered via HandiHaler® device. |
| Placebo for Revefenacin | DRUG | Placebo administered as double blind, double dummy via nebulization. |
| Placebo for Spiriva Handihaler® | DRUG | Placebo administered as double blind, double dummy via Spiriva HandiHaler®. |
| Revefenacin Inhalation Solution | DRUG | Revefenacin Inhalation Solution, 175 mcg/3 mL following a single nebulized inhaled 175 mcg (1 x 175 mcg/3 mL) dose administered under fasting conditions. |
Inclusion Criteria: * Participant is a male or female subject 40 years of age or older. * Participant is willing and able to provide signed and dated written informed consent. * Participant has a current or past cigarette smoking history (or equivalent for cigar or pipe smoking history) of at least...
Revefenacin is an investigational small molecule being developed for the treatment of Chronic Obstructive Pulmonary Disease (COPD). It is being studied in patients with moderate to very severe COPD, including those with low peak inspiratory flow rate. The drug is administered as an inhalation solution.
Revefenacin is being developed by Viatris Inc. (NASDAQ: VTRS). The company is conducting clinical trials to evaluate the drug's safety and efficacy in patients with Chronic Obstructive Pulmonary Disease (COPD).
Revefenacin is in Phase 3 clinical development for Chronic Obstructive Pulmonary Disease (COPD). Multiple Phase 3 trials have been completed, including studies in the United States and China. The drug is investigational and has not been approved by regulatory authorities.
Revefenacin has completed several clinical trials, including NCT03095456, a Phase 3 study in COPD patients with low peak inspiratory flow rate; NCT03573817, a safety study of Revefenacin and formoterol in COPD; and NCT05046795, a Phase 3 study in Chinese subjects with COPD. A Phase 1 bioavailability study, NCT05207111, was also completed.
No, Revefenacin is not the same as formoterol. They are different drugs that have been studied together in a clinical trial (NCT03573817) to evaluate their safety when administered in sequence and as a combination in patients with Chronic Obstructive Pulmonary Disease.