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Label indication Colchicine Tablets, USP are an alkaloid indicated for: Prophylaxis and treatment of gout flares in adults ( 1.1 ). Familial Mediterranean fever (FMF) in adults and children 4 years or older ( 1.2 ). 1.1 Gout Flares Colchicine Tablets, USP are indicated for prophylaxis and the treatment of acute gout flares. Prophylaxis of Gout Flares : Colchicine Tablets, USP are indicated for prophylaxis of gout flares. FDA label
Also known as High Dose Colchicine
Colchicine · 1 trial · 1 indication
Responders were defined as patients who achieved a ≥ 50% reduction in target joint pain score from baseline at 24 hours without using rescue drug, using an 11 point scale from 0 to 10, with 10 being the worst pain imaginable after beginning therapy.
| Arm | Type | Description |
|---|---|---|
| High Dose Colchicine | EXPERIMENTAL | After confirmation of a gout flare, patients were to begin standard dosing of colchicine 4.8mg (two capsules (1.8mg) initially followed by additional one capsule doses (0.6mg) every hour for an additional 6 doses). |
| Low Dose Colchicine | EXPERIMENTAL | Within 12 hours of a confirmed gout flare, patients were to begin the low dose colchicine regimen consisting of a total dose of 1.8 mg - two colchicine capsules initially (1.2 mg)followed an hour later by a single additional capsule of active drug(0.6 mg)then by 5 additional hourly doses of an identical looking placebo capsules |
| Placebo | PLACEBO_COMPARATOR | - |
| Name | Type | Description |
|---|---|---|
| High Dose Colchicine (4.8 mg total dose) | DRUG | At randomization, patients were given an identical looking blister pack containing (8) over encapsulated colchicine 0.6 mg tablets identical in appearance to placebo capsules. Patients were instructed to take 2 capsules initially (1.2 mg) followed by an additional capsule (0.6 mg) every hour for a total of six additional doses (total colchicine dose 4.8 mg) beginning within 12 hours of onset of a qualifying gout flare as confirmed by calling the gout flare call center. |
| Low Dose Colchicine (1.8mg total dose) | DRUG | At randomization, patients were given an identical looking blister pack containing (3) over encapsulated colchicine 0.6 mg tablets identical in appearance to placebo capsules and five placebo capsules. Patients were instructed to take 2 capsules initially (0.6 mg x 2) followed by an additional capsule every hour for a total of six additional doses (one active (0.6 mg) and 5 placebo capsules), a total colchicine dose = 1.8 mg) beginning within 12 hours of onset of a qualifying gout flare as confirmed by calling the gout flare call center |
| Placebo Control | OTHER | At randomization, patients were given an identical looking blister pack containing (8) placebo capsules identical in appearance to the study drug. Patients were instructed to take 2 capsules initially followed by an additional capsule every hour for a total of six additional doses beginning within 12 hours of onset of a qualifying gout flare as confirmed by calling the gout flare call center. |
Inclusion Criteria: 1. Patients of either gender and of any race ≥18 years of age. 2. If female, patients must be postmenopausal as evidenced by lack of menses for ≥12 consecutive months. 3. Patients must present with a confirmed diagnosis of gout. 4. Patients must have experienced ≥2 acute gouty a...
| Company | Ticker | Trials | Lead Phase | Drugs |
|---|---|---|---|---|
| Amgen Inc. | AMGN | 1 | PHASE3 | Pegloticase |
| Protalix BioTherapeutics, Inc. (DE) | PLX | 1 | PHASE2 | PRX-115 |
| Novo Nordisk A/S Sponsored ADR Class B | NVO | 1 | PHASE1 | NNC4004-0002 |
| Biogen Inc. | BIIB | 1 | PHASE2 | Plonmarlimab, Compound betamethasone |
Colchicine is a small molecule drug being developed for the treatment of gout, specifically for managing an acute gout flare. It is in Phase 3 clinical development under the name High Dose Colchicine, with a total dose of 4.8 mg, and is being developed by Takeda Pharmaceutical Company Limited.
Colchicine targets tubulin proteins, including TUBB4B, TUBB1, TUBA3C, TUBA4A, TUBB3, and TUBA1A. It acts as an inhibitor of these targets. This mechanism underlies its activity in the treatment of acute gout flares, the indication being studied in its clinical program.
Takeda Pharmaceutical Company Limited is developing colchicine, which is also referred to as High Dose Colchicine. Takeda trades under the ticker TAK. The drug is a small molecule in Phase 3 development for gout, a metabolic therapeutic area.
Colchicine is in Phase 3 clinical development for gout. It is an investigational drug and has not been approved. The Phase 3 program includes one completed trial, and there are currently no active trials listed for this asset.
Colchicine has been studied in the Phase 3 trial NCT00506883, titled MPC-004 for the Treatment of an Acute Gout Flare. The trial was completed, enrolled 185 participants, was randomized, double-blind, and placebo-controlled, and was conducted in the United States.
Yes, colchicine is also known as High Dose Colchicine, referring to a 4.8 mg total dose. This alternative name is used in the context of its Phase 3 development for acute gout flares by Takeda Pharmaceutical Company Limited.