Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Dosing 1: Atomoxetine · 1 trial · 1 indication
Compares high dose atomoxetine (80/10) versus baseline
| Arm | Type | Description |
|---|---|---|
| Dosing Period 1: Atomoxetine | ACTIVE_COMPARATOR | 3 days of atomoxetine 40 mg followed by 4 days of atomoxetine 80 mg. |
| Dosing Period 2-4: AD313 | EXPERIMENTAL | Week 2: atomoxetine 40 mg/dronabinol 2.5 mg Week 3: atomoxetine 80 mg/dronabinol 5 mg Week 4: atomoxetine 80 mg/dronabinol 10 mg |
| Name | Type | Description |
|---|---|---|
| Dosing 1: Atomoxetine | DRUG | Oral administration at bedtime |
| AD313 | DRUG | Escalating dose of AD313; Oral administration at bedtime |
Inclusion Criteria: Age and Sex 1. 25 to 65 years of age, inclusive, at the Screening Visit. Disease Measures 2. AHI 10 to 50 (hypopneas defined by 4% oxygen desaturation) 3. ≤25% of apneas are central or mixed apneas at V2 baseline PSG Weight 4. BMI between 18.5 and 40.0 kg/m2, inclusive, at the ...