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Label indication Alprazolam XR is indicated for the treatment of panic disorder with or without agoraphobia, in adults. Alprazolam XR is a benzodiazepine indicated for the treatment of panic disorder with or without agoraphobia, in adults. ( 1 ) FDA label
Alprazolam · 3 trials · 1 indication
| Arm | Type | Description |
|---|---|---|
| 1 | EXPERIMENTAL | Alprazolam Extended-Release Tablets 1 mg |
| 2 | ACTIVE_COMPARATOR | Xanax XR Tablets 1 mg |
| Name | Type | Description |
|---|---|---|
| Alprazolam Extended-Release Tablets 1 mg | DRUG | - |
| Xanax XR Tablets 1 mg | DRUG | - |
| Alprazolam Extended-Release Tablets 3 mg | DRUG | 3mg, single dose fasting |
| Xanax XR® Tablets (3 mg | DRUG | 3mg, single dose fasting |
| Xanax XR® Tablets 3 mg | DRUG | 3mg, single dose fed |
Inclusion Criteria: * 1\. Age: 18 years and older. 2. Sex: Male and/or non-pregnant, non-lactating female. 1. Women of childbearing potential must have negative serum beta human chorionic gonadotropin (beta-HCG) pregnancy tests performed within 14 days prior to the start of the study and on the ...
Alprazolam is a small molecule drug developed by Viatris Inc. (ticker VTRS). It is being studied in Phase 1 clinical development. The specific therapeutic indication for this program is undisclosed. Alprazolam is also known as Alprazolam Extended-release Tablets 3 mg, Alprazolam Extended-Release Tablets 3 mg, and Alprazolam Extended-Release Tablets 1 mg.
Alprazolam targets GABRA1, GABRB2, GABRG2, GABRB3, GABRA4, and GABRG3. It acts as a positive allosteric modulator. These targets are subunits of the GABA-A receptor complex. By binding at an allosteric site, the drug modulates receptor activity rather than directly activating it.
Alprazolam is developed by Viatris Inc., which trades under the ticker symbol VTRS. Viatris is the sponsor of the clinical program for this extended-release formulation. The company is responsible for the development and regulatory strategy for Alprazolam.
Alprazolam is in Phase 1 clinical development. It is an investigational drug and has not been approved by the FDA for the undisclosed indication being studied. All three of its registered trials are Phase 1 studies that have been completed, with no active trials currently ongoing.
Alprazolam has been studied in three completed Phase 1 trials: NCT00650299, NCT00647894, and NCT00647634. All three were conducted in the United States in healthy adult volunteers. Total enrollment across the trials was 66 participants. The studies were randomized and active-controlled, comparing Alprazolam extended-release tablets to Xanax XR tablets.
Alprazolam extended-release tablets are the investigational formulation developed by Viatris Inc. Xanax XR tablets were used as the active comparator in the clinical trials. The trials directly compared Alprazolam extended-release tablets at 1 mg and 3 mg doses against Xanax XR tablets at matching doses.