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Label indication Effexor XR is indicated in adults for the treatment of: • Major Depressive Disorder (MDD) [see Clinical Studies (14.1) ] • Generalized Anxiety Disorder (GAD) [see Clinical Studies (14.2) ] • Social Anxiety Disorder (SAD) [see Clinical Studies (14.3) ] • Panic Disorder (PD) [see Clinical Studies (14.4) ] Effexor XR is a serotonin and norepinephrine reuptake inhibitor (SNRI) indicated for the treatment of adults with:… FDA label
Also known as Venlafaxine Hydrochloride, Effexor® XR
Venlafaxine · 5 trials · 1 indication
Bioequivalence based on Venlafaxine Cmax (maximum observed concentration of drug substance in plasma).
Bioequivalence based on Venlafaxine AUC0-t (area under the concentration-time curve from time zero to time of last measurable concentration).
Bioequivalence based on Venlafaxine AUC0-inf (area under the concentration-time curve from time zero to infinity).
Bioequivalence based on Cmax
Bioequivalence based on AUC0-inf
Bioequivalence based on AUC0-t
| Arm | Type | Description |
|---|---|---|
| Investigational Test Product | EXPERIMENTAL | Venlafaxine Hydrochloride 150 mg Extended-Release Capsules. |
| Reference Listed Drug | ACTIVE_COMPARATOR | Effexor® XR 150 mg Extended-Release Capsules |
| Venlafaxine | EXPERIMENTAL | Venlafaxine 25 mg Tablet (test) dosed in first period followed by Effexor® 25 mg Tablet (reference) dosed in second period |
| Effexor® | ACTIVE_COMPARATOR | Effexor® 25 mg Tablet (reference) dosed in first period followed by Venlafaxine 25 mg Tablet (test) dosed in second period |
| Name | Type | Description |
|---|---|---|
| Venlafaxine Hydrochloride | DRUG | 150 mg Extended-Release Capsule |
| Effexor® XR | DRUG | 150 mg Extended-Release Capsule |
| Venlafaxine 25 mg Tablets | DRUG | 1 x 25 mg, single-dose fasting |
| Effexor® 25 mg Tablets | DRUG | 1 x 25 mg, single-dose fasting |
Inclusion Criteria: * Members of the community at large. * Subjects will be females and/or males, non-smokers, 18 years of age and older. * Female subjects will be postmenopausal or surgically sterilized. Exclusion Criteria: * Clinically significant illness within 4 weeks of the administration of...
Venlafaxine is a small molecule drug developed by Teva Pharmaceutical Industries Limited, which trades as TEVA. It is also known as Venlafaxine Hydrochloride and Venlafaxine 25 mg Tablets. The program is in Phase 1 clinical development, and the specific therapeutic indication has not been disclosed.
Venlafaxine targets SLC6A2 and SLC6A4. It acts as an inhibitor of these targets, which are the norepinephrine and serotonin transporters. This target profile places it in the inhibitor class of small molecule therapeutics.
Venlafaxine is developed by Teva Pharmaceutical Industries Limited, which is listed under the ticker symbol TEVA. Teva is the sponsor behind the clinical development program for this small molecule asset.
Venlafaxine is in Phase 1 clinical development. All five of its recorded trials are Phase 1 studies, and all five are completed. There are currently no active trials listed for this program.
Venlafaxine has been studied in five completed Phase 1 trials, including NCT01282814, NCT01282801, NCT01260896, and NCT00834964. These trials enrolled healthy adult volunteers in Canada and evaluated extended-release capsules and 25 mg tablets under fed and fasting conditions.
Yes, Venlafaxine Hydrochloride is an alternative name for Venlafaxine, along with Venlafaxine 25 mg Tablets. These names refer to the same small molecule drug candidate developed by Teva Pharmaceutical Industries Limited.