Colchicine

Scilex Holding Company Sets Launch Price of $595 per 150ml bottle of Gloperba®, its First and Only Liquid Oral Version of the Anti-Gout Medicine Colchicine Indicated for the Prophylaxis of Painful Gout Flares in Adults; Expected Plans to Launch in the Fir

Retrieved on: 
Tuesday, March 5, 2024

Gloperba® is the first and only liquid oral version of the anti-gout medicine colchicine indicated for the prophylaxis of painful gout flares in adults.

Key Points: 
  • Gloperba® is the first and only liquid oral version of the anti-gout medicine colchicine indicated for the prophylaxis of painful gout flares in adults.
  • Gout is a painful arthritic disorder affecting an estimated 9.2 million people in the United States1.
  • These patients may benefit from flexible dosing offered by Gloperba®4
    Scilex plans to launch Gloperba® in the first half of 2024 with a launch price of $595 per 150ml bottle of liquid colchicine formulation.
  • Gloperba is the only FDA approved liquid formulation of colchicine for the prophylaxis of acute gout flares.

PK MED Announces FDA Clearance to Initiate Its Clinical Program for PKM-01, for Local Treatment of Gout Flares, Directly by a Phase 2 Trial

Retrieved on: 
Monday, February 26, 2024

During a Type B pre-IND meeting1, the Food and Drug Administration gave its clearance to directly initiate the clinical program for PKM-01 with a phase 2 trial for gout patients, without undertaking phase 1 studies.

Key Points: 
  • During a Type B pre-IND meeting1, the Food and Drug Administration gave its clearance to directly initiate the clinical program for PKM-01 with a phase 2 trial for gout patients, without undertaking phase 1 studies.
  • PKM-01 is a local intra-articular injection treatment for gout flares, developed by PK MED, aiming to provide a fast an effective pain relief and powerful and safe anti-inflammatory effect.
  • Thanks to its low-risk toxicity profile, PKM-01's clinical program will start directly in phase 2, which should considerably speed up time-to-market.
  • PK MED is now entering the fund-raising phase to finance PKM-01 phase 2 clinical trials.

Lupus Research Alliance Announces Recipients of the Lupus Mechanisms and Targets Award

Retrieved on: 
Wednesday, February 28, 2024

NEW YORK, Feb. 28, 2024 /PRNewswire/ -- The Lupus Research Alliance (LRA) is pleased to announce the recent recipients of the Lupus Mechanisms and Targets Award (LMTA), whose research will investigate molecular pathways or targets that will lead to new or improved therapies for individuals with systemic lupus erythematosus (SLE).

Key Points: 
  • NEW YORK, Feb. 28, 2024 /PRNewswire/ -- The Lupus Research Alliance (LRA) is pleased to announce the recent recipients of the Lupus Mechanisms and Targets Award (LMTA), whose research will investigate molecular pathways or targets that will lead to new or improved therapies for individuals with systemic lupus erythematosus (SLE).
  • The development of targeted treatments is hindered by an incomplete understanding of lupus and its devastating complications.
  • These seven talented investigators will identify targets for new treatments and test novel therapeutic avenues to revolutionize the field and improve the lives of individuals with lupus.
  • Surgical biopsies of the kidneys are often needed to diagnose lupus nephritis (LN), kidney inflammation caused by lupus that can result in severe and sometimes life-threatening organ damage.

Scilex Holding Company Announces Results from Market Research with Rheumatologists Reveal a High Degree of Interest in Gloperba® as a Liquid Colchicine Formulation Designed for Precision Dosing

Retrieved on: 
Tuesday, December 19, 2023

Gloperba® is the first and only liquid oral version of the anti-gout medicine colchicine indicated for the prophylaxis of painful gout flares in adults.

Key Points: 
  • Gloperba® is the first and only liquid oral version of the anti-gout medicine colchicine indicated for the prophylaxis of painful gout flares in adults.
  • Gout is a painful arthritic disorder affecting an estimated 9.2 million people in the United States1.
  • As gout cases increase every year, treatment requirements increase.
  • The gout treatment market is projected to reach $2.0 billion in the U.S. by 2028 with a well-defined area of unmet need.2
    Over 17% of gout patients had gastrointestinal side effects like diarrhea.

Phathom Pharmaceuticals Announces FDA Approval of Reformulated Vonoprazan Tablets for VOQUEZNA® TRIPLE PAK® (vonoprazan, amoxicillin, clarithromycin) and VOQUEZNA® DUAL PAK® (vonoprazan, amoxicillin) for the Treatment of H. pylori Infection in Adults

Retrieved on: 
Monday, October 30, 2023

The full Prescribing Information for VOQUEZNA TRIPLE PAK and VOQUEZNA DUAL PAK can be found here.

Key Points: 
  • The full Prescribing Information for VOQUEZNA TRIPLE PAK and VOQUEZNA DUAL PAK can be found here.
  • VOQUEZNA® TRIPLE PAK® (vonoprazan tablets, amoxicillin capsules, clarithromycin tablets) and VOQUEZNA® DUAL PAK® (vonoprazan tablets, amoxicillin capsules) are co-packaged prescription medicines for the treatment of a Helicobacter pylori (H. pylori) bacterial infection in adults.
  • It is not known if VOQUEZNA TRIPLE PAK and VOQUEZNA DUAL PAK are safe and effective in children.
  • Stop taking VOQUEZNA TRIPLE PAK or VOQUEZNA DUAL PAK if you are diagnosed with mononucleosis and call your doctor right away.

Endo Launches Colchicine Capsules, Generic Version of MITIGARE®

Retrieved on: 
Thursday, November 2, 2023

DUBLIN, Nov. 2, 2023 /PRNewswire/ -- Endo International plc (OTC: ENDPQ) announced today that one of its operating companies, Par Pharmaceutical, Inc., has begun shipping colchicine 0.6 mg capsules, a generic version of Hikma's MITIGARE®.

Key Points: 
  • DUBLIN, Nov. 2, 2023 /PRNewswire/ -- Endo International plc (OTC: ENDPQ) announced today that one of its operating companies, Par Pharmaceutical, Inc., has begun shipping colchicine 0.6 mg capsules, a generic version of Hikma's MITIGARE®.
  • This is the first generic colchicine capsule approved by the U.S. Food and Drug Administration.
  • Patients with renal or hepatic impairment should not be given colchicine with drugs that inhibit both P-glycoprotein and CYP3A4 inhibitors.
  • Combining these dual inhibitors with colchicine in patients with renal or hepatic impairment has resulted in life-threatening or fatal colchicine toxicity.

Endo Launches Colchicine Capsules, Generic Version of MITIGARE®

Retrieved on: 
Thursday, November 2, 2023

DUBLIN, Nov. 2, 2023 /PRNewswire/ -- Endo International plc (OTC: ENDPQ) announced today that one of its operating companies, Par Pharmaceutical, Inc., has begun shipping colchicine 0.6 mg capsules, a generic version of Hikma's MITIGARE®.

Key Points: 
  • DUBLIN, Nov. 2, 2023 /PRNewswire/ -- Endo International plc (OTC: ENDPQ) announced today that one of its operating companies, Par Pharmaceutical, Inc., has begun shipping colchicine 0.6 mg capsules, a generic version of Hikma's MITIGARE®.
  • This is the first generic colchicine capsule approved by the U.S. Food and Drug Administration.
  • Patients with renal or hepatic impairment should not be given colchicine with drugs that inhibit both P-glycoprotein and CYP3A4 inhibitors.
  • Combining these dual inhibitors with colchicine in patients with renal or hepatic impairment has resulted in life-threatening or fatal colchicine toxicity.

The Montreal Heart Institute Welcomes FDA Approval of Colchicine for the Treatment of Cardiovascular Diseases

Retrieved on: 
Friday, June 23, 2023

MONTREAL, June 23, 2023 (GLOBE NEWSWIRE) -- The Montreal Heart Institute (MHI) welcomes the approval by the United States Food and Drug Administration (FDA) of colchicine for cardiovascular prevention.

Key Points: 
  • MONTREAL, June 23, 2023 (GLOBE NEWSWIRE) -- The Montreal Heart Institute (MHI) welcomes the approval by the United States Food and Drug Administration (FDA) of colchicine for cardiovascular prevention.
  • Two large cardiovascular clinical studies have been conducted with colchicine: COLCOT , conducted by Dr. Jean-Claude Tardif, Director of Research at the Montreal Heart Institute, and LoDoCo-2 , led by Dr. Stefan M. Nidorf from Australia.
  • "We have known for a long time that inflammation contributes to atherosclerosis and increases cardiovascular risk.
  • The results of this study demonstrated that colchicine reduced the risk of cardiovascular events by 31% when added to standard prevention treatments in these patients.

Caristo Diagnostics Applauds FDA Approval of Colchicine as First Anti-Inflammatory Drug for Cardiovascular Disease

Retrieved on: 
Thursday, June 22, 2023

OXFORD, England, June 22, 2023 /PRNewswire/ -- Caristo Diagnostics Limited, a global leader in cardiac and vascular disease diagnostics and risk prediction, applauds the FDA's decision to approve colchicine as first anti-inflammatory drug for cardiovascular disease. Caristo reaffirms its commitment to lead innovations in CCTA based coronary inflammation detection and cardiovascular risk prediction, so every coronary inflammation patient can be identified and treated by appropriate therapy including the anti-inflammatory drug approved by the FDA.

Key Points: 
  • OXFORD, England, June 22, 2023 /PRNewswire/ -- Caristo Diagnostics Limited , a global leader in cardiac and vascular disease diagnostics and risk prediction, applauds the FDA's decision to approve colchicine as first anti-inflammatory drug for cardiovascular disease.
  • Caristo reaffirms its commitment to lead innovations in CCTA based coronary inflammation detection and cardiovascular risk prediction, so every coronary inflammation patient can be identified and treated by appropriate therapy including the anti-inflammatory drug approved by the FDA.
  • "The FDA approval of colchicine is an important tool for us to reduce coronary inflammation, a main culprit for heart attack."
  • Caristo Diagnostics was founded in 2018 to commercialize the proprietary CaRi-Heart® coronary inflammation diagnostic technology based on PVAT quantification.

Caristo Diagnostics Applauds FDA Approval of Colchicine as First Anti-Inflammatory Drug for Cardiovascular Disease

Retrieved on: 
Thursday, June 22, 2023

OXFORD, England, June 22, 2023 /PRNewswire/ -- Caristo Diagnostics Limited, a global leader in cardiac and vascular disease diagnostics and risk prediction, applauds the FDA's decision to approve colchicine as first anti-inflammatory drug for cardiovascular disease. Caristo reaffirms its commitment to lead innovations in CCTA based coronary inflammation detection and cardiovascular risk prediction, so every coronary inflammation patient can be identified and treated by appropriate therapy including the anti-inflammatory drug approved by the FDA.

Key Points: 
  • OXFORD, England, June 22, 2023 /PRNewswire/ -- Caristo Diagnostics Limited , a global leader in cardiac and vascular disease diagnostics and risk prediction, applauds the FDA's decision to approve colchicine as first anti-inflammatory drug for cardiovascular disease.
  • Caristo reaffirms its commitment to lead innovations in CCTA based coronary inflammation detection and cardiovascular risk prediction, so every coronary inflammation patient can be identified and treated by appropriate therapy including the anti-inflammatory drug approved by the FDA.
  • "The FDA approval of colchicine is an important tool for us to reduce coronary inflammation, a main culprit for heart attack."
  • Caristo Diagnostics was founded in 2018 to commercialize the proprietary CaRi-Heart® coronary inflammation diagnostic technology based on PVAT quantification.