News
Article
Oral Colchicine Receives FDA Orphan Drug Designation for Pericarditis
Author(s):
Key Takeaways
- Colchicine's liquid oral form offers dosing flexibility, aiding patients with swallowing difficulties and those with renal or hepatic impairments.
- As an adjunct to NSAIDs, colchicine reduces pericarditis occurrences, providing an alternative treatment option.
An oral dose of 0.6 mg per 5 ml of colchicine could aid individuals that have trouble with swallowing pills.
The FDA has approved the request for an orphan drug designation (ODD) for colchicine (Gloperba; Scilex Holding Company), the first and only liquid oral version of the anti-gout medicine for the treatment of pericarditis.1
Image credit: lexiconimages | stock.adobe.com
An oral dose of 0.6 mg per 5 ml of colchicine could aid individuals that have trouble with swallowing pills. Additionally, colchicine could offer adjustable dosing, titration, and dose-reduction options for individuals with gout and renal or hepatic impairment, reducing adverse events.1
Colchicine for Pericarditis
As an adjunctive therapy to nonsteroidal anti-inflammatory drugs (NSAIDs), colchicine could reduce the number of pericarditis occurrences in individuals with recurrent or acute pericarditis.2 According to the American Heart Association, pericarditis is inflammation of the pericardium that causes chest pain due to the sac’s layers rubbing against the heart. Differing from pain caused by a heart attack, chest pain related to pericarditis is often a sharp, stabbing pain that can occur suddenly in the middle or within the left side of the chest.3
“Patients will experience pain in their chest; sometimes, some will describe it as a tightness. Generally, if they are lying back, the symptoms are worse—so, the pain will be worse—if they sit up and/or lean forward, the pain goes away and can lessen,” Jessica Farrell, PharmD, clinical pharmacist in the Division of Rheumatology, Albany Medical Center, and faculty professor in the Department of Pharmacy Practice, Albany College of Pharmacy and Health Sciences, said in an interview with Pharmacy Times®. “[Patients] can also have [electrocardiogram] changes; there can be fluid that builds up around the sac of the heart, which can be seen on imaging. Some patients will have more pain if they cough or if they take a deep breath... [but] those are some of the common symptoms that we [see].”4
In most cases pericarditis is mild and clears on its own with rest and minimal treatment; however, in more intense cases treatment is needed.3 Most individuals are treated with aspirin and ibuprofen, and colchicine is used to reduce the pain and inflammation.5
Broader Uses of Colchicine and Important Considerations
Colchicine is also available as a capsule and tablet to prevent or treat attacks of gout and reduce the risk of heart attack, stroke, certain types of heart procedures, and cardiovascular death in individuals with atherosclerosis. The NSAID is also indicated to treat a rare familial Mediterranean fever, which is a rare condition, according to Mayo Clinic.6
Colchicine is used in 2 main ways: regular, low-dose intake for long-term prevention of inflammation-related problems and short-term, high-dose intake to relieve acute attacks. However, preventative treatment with smaller doses is reported to carry a lower risk of serious adverse effects compared to the higher doses used during an attack.6
“There are a lot of drug interactions with colchicine, and tolerability can be a concern because a lot of patients will experience loose stools or diarrhea with it, and we do usually need to have them on a treatment dose, so twice a day dosing...but those are some of the limitations that we have with colchicine,” Farrell said.4
If approved, Gloperba could further treatment options for individuals that need colchicine treatment as the first and only liquid oral version of the anti-gout medication.1
REFERENCES
1. Scilex Holding Company Announces FDA Has Approved Our Request for the Orphan Drug Designation for Colchicine for the Treatment of Pericarditis. Scilex Holding Company. News release. April 16, 2025. Accessed April 21, 2025. https://www.globenewswire.com/news-release/2025/04/16/3062839/0/en/Scilex-Holding-Company-Announces-FDA-Has-Approved-Our-Request-for-the-Orphan-Drug-Designation-for-Colchicine-for-the-Treatment-of-Pericarditis.html
2. Alabed S, Cabello J, Irving G, Qintar M, Burls A. Colchicine for pericarditis. Cochrane Library. Published August 28, 2014. Accessed April 21, 2025. https://pmc.ncbi.nlm.nih.gov/articles/PMC10645160/#:~:text=Colchicine%2C%20as%20adjunctive%20therapy%20to,recurrent%20pericarditis%20or%20acute%20pericarditis
3. What Is Pericarditis? American Heart Association. News release. Updated June 6, 2024. Accessed April 21, 2025. https://www.heart.org/en/health-topics/pericarditis/what-is-pericarditis#:~:text=Pericarditis%20is%20inflammation%20of%20the,them%20as%20the%20heart%20beats.
4. McGovern G. Pharmacists Educate and Bridge Communication Gaps for Patients With Pericarditis. Pharmacy Times. February 14, 2025. Accessed April 21, 2025. https://www.pharmacytimes.com/view/pharmacists-educate-and-bridge-communication-gaps-for-patients-with-pericarditis
5. Treatment of Pericarditis. American Heart Association. News release. Updated June 7, 2024. Accessed April 21, 2025. https://www.heart.org/en/health-topics/pericarditis/treatment-of-pericarditis
6. Colchicine (oral route). Mayo Clinic. News release. Updated April 1, 2025. Accessed April 21, 2025. https://www.mayoclinic.org/drugs-supplements/colchicine-oral-route/description/drg-20067653#cmp-body
