Colchicine comes from a plant called Colchicum autumnale, or autumn crocus, which is a member of the lily family. Plant extracts containing colchicine have been used to prevent gout flares for more than 2,000 years.1 West-Ward Pharmaceuticals (now known as Hikma Pharmaceuticals USA Inc.) received FDA approval for Mitigare® (colchicine) 0.6 mg capsules in 2014.

Mitigare® is indicated for prophylaxis of gout flares in adults. The safety and effectiveness of Mitigare® for acute treatment of gout flares during prophylaxis has not been studied. Mitigare® is not an analgesic medication and should not be used to treat pain from other causes.


 

History of Mitigare® (colchicine)

2006 
The U.S. Food and Drug Administration (FDA) announced a new initiative to promote testing of medicines in use prior to the agency’s existence. Despite the fact that colchicine had been used to prevent gout flares for hundreds of years, unapproved formulations of the drug were banned a few years later.

2009 
The FDA approved Colcrys® (colchicine, USP) 0.6 mg tablet, which launched at a significantly higher price than pre-existing unapproved colchicine generics.

2010 
The FDA banned the sale of unapproved colchicine (produced by West-Ward Pharmaceuticals and others), requiring patients to pay a premium price for Colcrys® or abandon colchicine therapy.

2014 
The FDA approved Mitigare® (colchicine) 0.6 mg capsules, the first and only other branded colchicine product for prevention of gout flares in adults.

2015 
Mitigare® and its authorized generic launch, generating competition and creating a possibility for people with gout to save on colchicine treatment for prevention of gout flares.

2018 
Hikma Pharmaceuticals USA continues to provide Mitigare® and its authorized generic colchicine 0.6 mg capsules as affordable options to help adults prevent gout flares.

Pathway to Approval

To provide an affordable gout flare prevention option to patients, West-Ward (now known as Hikma Pharmaceuticals USA) secured FDA approval for Mitigare® (colchicine) via the 505(b)(2) pathway.

  • A 505(b)(2) application is a New Drug Application that contains full reports of safety and efficacy data. However, some of the data is from studies not conducted by or for the applicant.
  • Medications approved under section 505(b)(2) are considered safe and effective for their improved indications.
  • Many drugs have been approved via the 505(b)(2) pathway, including Colcrys®.

 

Commitment to affordable gout flare prevention

West-Ward Pharmaceuticals brought Mitigare® to market to offer patients an affordable treatment option for gout flare prevention.

  • Since the launch of Mitigare® in 2014, the price of Colcrys® has increased by a total of 24.4 percent.
  • Hikma Pharmaceuticals USA continues to offer the lowest-priced brand name and authorized generic colchicine 0.6 mg capsules for adult gout flare prevention.
 
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References

  1. Dubchak N, Falasca G. New and improved strategies for the treatment of gout. Int J Nephrol Renovasc Dis. 2010;3:145-166.

Important Safety Information for Mitigare® (colchicine) 0.6 mg capsules

  • Colchicine 0.6 mg capsules are contraindicated in patients with renal or hepatic impairment who are currently prescribed drugs that inhibit both P-gp and CYP3A4. Combining these dual inhibitors with colchicine in patients with renal or hepatic impairment has resulted in life-threatening or fatal colchicine toxicity. Patients with both renal and hepatic impairment should not be given Mitigare®.
  • Fatal overdoses have been reported with colchicine in adults and children. Keep Mitigare® out of the reach of children.
  • Blood dyscrasias such as myelosuppression, leukopenia, granulocytopenia, thrombocytopenia, and aplastic anemia have been reported with colchicine used in therapeutic doses.
  • Monitor for toxicity and if present consider temporary interruption or discontinuation of colchicine.
  • Drug interaction with dual P-gp and CYP3A4 inhibitors: Co-administration of colchicine with dual P-gp and CYP3A4 inhibitors has resulted in life-threatening interactions and death.
  • Neuromuscular toxicity and rhabdomyolysis may occur with chronic treatment with colchicine in therapeutic doses, especially in combination with other drugs known to cause this effect. Patients with impaired renal function and elderly patients (including those with normal renal and hepatic function) are at increased risk. Consider temporary interruption or discontinuation of Mitigare®.
  • The most commonly reported adverse reactions with colchicine are gastrointestinal symptoms, including diarrhea, nausea, vomiting, and abdominal pain.

Indication

Mitigare® is indicated for prophylaxis of gout flares in adults. The safety and effectiveness of Mitigare for acute treatment of gout flares during prophylaxis has not been studied.

Mitigare® is not an analgesic medication and should not be used to treat pain from other causes.

For Full Prescribing Information please CLICK HERE and for Medication Guide CLICK HERE.

You are encouraged to report negative side effects of prescription drugs to the FDA.

Visit www.fda.gov/medwatch, or call 1-800-FDA-1088.

Manufactured by: West-Ward Pharmaceuticals Corp., Eatontown, NJ 07724

Important Safety Information for Mitigare® (colchicine) 0.6 mg capsules

  • Colchicine 0.6 mg capsules are contraindicated in patients with renal or hepatic impairment who are currently prescribed drugs that inhibit both P-gp and CYP3A4. Combining these dual inhibitors with colchicine in patients with renal or hepatic impairment has resulted in life-threatening or fatal colchicine toxicity. Patients with both renal and hepatic impairment should not be given Mitigare®.
  • Fatal overdoses have been reported with colchicine in adults and children. Keep Mitigare® out of the reach of children.