Colchicine
- Generic Name
- Colchicine
- Brand Names
- Colcrys, Gloperba, Lodoco, Mitigare
- Drug Type
- Small Molecule
- Chemical Formula
- C22H25NO6
- CAS Number
- 64-86-8
- Unique Ingredient Identifier
- SML2Y3J35T
- Background
Colchicine is an alkaloid drug derived from a plant belonging to the Lily family, known as Colchicum autumnale, or "autumn crocus." Its use was first approved by the FDA in 1961. Colchicine is used in the treatment of gout flares and Familial Mediterranean fever, and prevention of major cardiovascular events. It has also been investigated in other inflammatory and fibrotic conditions.
- Indication
Colchicine is indicated for the prophylaxis and treatment of gout flares. It is also indicated in Familial Mediterranean fever (FMF) in children and adults of four years of age and older. It is also indicated to reduce the risk of myocardial infarction (MI), stroke, coronary revascularization, and cardiovascular death in adult patients with established atherosclerotic disease or with multiple risk factors for cardiovascular disease.
Some off-label uses of colchicine include the treatment of the manifestations of Behcet's syndrome, pericarditis, and postpericardiotomy syndrome.
- Associated Conditions
- Behcet's Syndrome, Cardiovascular Mortality, Coronary Revascularization, Familial Mediterranean Fever (FMF ), Gout Flares, Myocardial Infarction, Pericarditis, Postpericardiotomy Syndrome, Stroke
SP-102 Shows Clinically Meaningful Results for Sciatica Treatment in CLEAR Trial Analysis
• Scilex Holding Company presented post-hoc analysis of the C.L.E.A.R. trial demonstrating clinically meaningful safety and efficacy of SP-102 (SEMDEXA™) for lumbosacral radicular pain at the ASIPP Annual Meeting.
• The analysis showed clear separation between SP-102 and placebo in multiple endpoints, with enhanced results in the modified intent-to-treat population that received confirmed study drug.
• SP-102's viscous gel formulation was specifically designed as a safer alternative to current off-label products that carry warnings about potentially dangerous and life-threatening adverse events.
FDA Grants Orphan Drug Designation to Scilex's Liquid Colchicine for Pericarditis Treatment
• Scilex Holding Company has received FDA orphan drug designation for colchicine in treating pericarditis, potentially providing seven years of market exclusivity upon approval.
• Gloperba®, Scilex's liquid oral colchicine formulation, offers advantages for patients with swallowing difficulties and allows for more precise dosing adjustments, particularly beneficial for those with renal or hepatic impairment.
• Pericarditis, an inflammation of the membrane surrounding the heart, affects fewer than 200,000 individuals in the United States and represents a significant unmet medical need in cardiovascular care.
Scilex Seeks FDA Approval for ELYXYB in Acute Pain Management
• Scilex Holding Company has submitted a Supplemental New Drug Application (SNDA) to the FDA for ELYXYB in acute pain management.
• ELYXYB, an oral solution of celecoxib, has demonstrated significant pain relief in a study involving post-dental surgery patients.
• The company aims to provide a non-opioid alternative for acute pain, addressing the need for opioid-sparing pain management.
• The FDA's decision on the SNDA will determine ELYXYB's role in the $3 billion U.S. acute pain market.
Scilex Bio's KDS2010 Shows Promise in Phase 2 Trials for Obesity and Alzheimer's
• Scilex Bio's KDS2010, a reversible MAO-B inhibitor, is in Phase 2 trials for obesity, with U.S. patient enrollment planned for 2025, targeting metabolism without affecting appetite.
• Phase 2 trials for KDS2010 in Alzheimer's are underway, enrolling 114 patients in South Korea, with plans to expand to the U.S. in 2025.
• KDS2010 uniquely targets astrocytic GABA inhibition, potentially improving cognitive function in Alzheimer's and offering advantages over existing GLP-1 obesity treatments.
• Phase 1 trials demonstrated KDS2010's favorable safety, tolerability, and pharmacokinetics for once-daily dosing, positioning it for further development in both disease areas.
Scilex Presents Data on GLOPERBA® for Gout Flare Prophylaxis in Renally Impaired Patients
• Scilex Holding Company presented data on GLOPERBA® (colchicine oral solution) at the 2024 American College of Rheumatology Convergence conference.
• GLOPERBA® is highlighted as the first and only liquid colchicine formulation allowing for precision dosing in at-risk gout patients.
• The updated GLOPERBA® label includes dosing adjustments for patients with severe renal impairment, allowing a reduced daily dose of 0.3 mg/day.
• Pharmacokinetic model-derived dosing for moderate and severe chronic kidney disease patients requiring lower precision dosing was presented.
Scilex's SP-103 Lidocaine Topical System Receives Positive FDA Feedback for Chronic Neck Pain
• Scilex Pharmaceuticals gains FDA agreement on NDA path for SP-103, a triple-strength lidocaine topical system, after a successful Phase II meeting.
• SP-103 targets chronic neck pain associated with muscle spasms, with potential peak sales projected at $1.2 billion annually.
• The next-generation formulation of ZTlido aims to provide more effective pain relief through a higher concentration of lidocaine.
• Phase III trials are planned to further evaluate SP-103, with Scilex emphasizing its technology's advantage in delivering higher lidocaine concentrations.
Scilex Receives FDA Guidance for SP-103, a Novel Topical Treatment for Chronic Neck Pain
• Scilex Pharmaceuticals secured FDA agreement on the NDA path for SP-103, a high-concentration lidocaine topical system, after a successful end-of-Phase II meeting.
• SP-103, a triple-strength formulation of ZTlido, targets chronic neck pain associated with muscle spasms, addressing a significant market estimated at $134.5 billion.
• Market research projects SP-103 could achieve peak sales of $1.2 billion annually within six years post-launch, driven by substantial utilization intent.
• Scilex is also exploring strategic options, including a potential spin-off or public listing of Scilex Pharmaceuticals Inc., to maximize company value.
Scilex's SP-103 Receives Positive FDA Feedback, Paving Way for Phase III Trials in Chronic Neck Pain
• Scilex Pharmaceuticals' SP-103, a triple-strength lidocaine topical system, has received positive feedback from the FDA, clearing the path for Phase III trials.
• SP-103 targets the chronic neck pain market, with potential peak sales projected to reach $1.2 billion annually within six years post-launch.
• The company's existing portfolio includes three FDA-approved products: ZTlido, ELYXYB, and Gloperba, bolstering its position in non-opioid pain management.
• Scilex is considering strategic options, including a potential spinoff or public listing, to maximize shareholder value.
Scilex Pharmaceuticals Achieves FDA Agreement on NDA Path for SP-103 in Chronic Neck Pain
• Scilex Pharmaceuticals secured FDA agreement on the NDA path for SP-103, a lidocaine topical system 5.4%, following a successful end-of-Phase II meeting.
• SP-103, a next-generation, triple-strength formulation of ZTlido, targets chronic neck pain associated with muscle spasms, a market projected to reach $134.5 billion.
• Market research suggests SP-103 could achieve peak sales of $1.2 billion annually within six years post-launch, driven by substantial utilization intent.
• Scilex is also considering strategic options to maximize company value, including a potential spin-off or public listing of Scilex Pharmaceuticals Inc.
Drug Development Updates
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