Drug intelligence / Profile preview

Gaboxetine

Development stage
Approved
Lead developer
Physician Therapeutics
Modality
Small Molecules
Administration
Oral
01

Overview

**Gaboxetine** is an unapproved oral convenience kit marketed by Physician Therapeutics that co-packages fluoxetine hydrochloride capsules with GABAdone, a choline-containing medical-food formulation comprising amino acids and polyphenol ingredients for dietary management of sleep disorders, including sleep disorders associated with anxiety. Fluoxetine is a small-molecule selective serotonin reuptake inhibitor that inhibits the sodium-dependent serotonin transporter, increasing serotonergic signaling. The label presents fluoxetine indications including major depressive disorder, obsessive-compulsive disorder, bulimia nervosa, and panic disorder; however, the Gaboxetine product label states that FDA has not found the product safe and effective and that its labeling has not been FDA approved. ([dailymed.nlm.nih.gov](https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=52057058-abdb-44ed-b60d-a718c97fbfda))

Brand names
Gaboxetine
Other names
fluoxetine hydrochloride + choline
02

Targets

CACNA2D1 (Voltage-gated calcium channel subunit alpha2/delta-1)α2δ (Voltage-gated calcium channel alpha-2-delta subunit)

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