Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
orvepitant · 2 trials · 2 indications
The CAPS was a 30-item clinical interview. Both frequency (0: never; 4: daily or all the time) and intensity (0: none or no problem with symptoms; 4: extreme, incapacitating) ratings were made on a 5-point scale. The CAPS total severity score was based on the 17 items that assess the frequency and intensity of PTSD symptoms. There were 8 items assessing associated features (guilt, hopelessness, memory impairment, overall response validity, global PTSD severity, global improvement and social and occupational impairment). The total score 0-136, higher scores means more severity, \< 20: few symptoms or being asymptomatic, 20-39: mild or subthreshold PTSD, 40-59: threshold and moderate PTSD, 60-79: severe PTSD symptoms and \> 80: extreme PTSD symptoms. The change from Baseline was calculated by subtracting the Baseline values from the individual post-randomization values. Baseline was defined as value on Day 1 (pre-dose).
| Arm | Type | Description |
|---|---|---|
| Orvepitant 60 mg | EXPERIMENTAL | 60 mg/day |
| Placebo | PLACEBO_COMPARATOR | - |
| Arm 1 | EXPERIMENTAL | Orvepitant 60 mg |
| Name | Type | Description |
|---|---|---|
| orvepitant | DRUG | Neurokinin-1 (NK-1) antagonist |
| Placebo | OTHER | Inactive placebo to match orvepitant 60 mg dosage form |
Inclusion Criteria: * Aged 18-64 years, inclusive. * A primary diagnosis of noncombat-related Post traumatic Stress Disorder (PTSD) * Subjects with symptom severity considered to be at least moderate to severe. Exclusion Criteria: * Subjects whose symptoms are better accounted for by a diagnosis ...
Orvepitant is an investigational small molecule being developed for psychiatric conditions, specifically depressive disorder and post-traumatic stress disorder (PTSD). It is currently in clinical development and has not been approved by regulatory authorities.
Orvepitant is being developed by GSK plc, a global pharmaceutical company listed on the London Stock Exchange under the ticker GSK. The company is conducting clinical trials to evaluate the drug's safety and efficacy in psychiatric indications.
Orvepitant is in Phase 1 of clinical development. While one Phase 2 trial has been completed, the drug remains investigational and is not yet approved. Its development status reflects early-stage evaluation of its potential in depressive disorder and PTSD.
Orvepitant has been studied in two completed clinical trials. NCT00843011 was a Phase 1 food and relative bioavailability study in healthy volunteers with depressive disorder, enrolling 14 participants in Italy. NCT01000493 was a Phase 2 trial in 132 adults with post-traumatic stress disorder in the United States.
Yes, Orvepitant is also known as GW823296. This alternative name appears in clinical trial records, where the drug is referred to as Orvepitant (GW823296) in studies evaluating its effects on post-traumatic stress disorder.