Once-daily mesalamine granules for ulcerative colitis

Lawlor, Garrett; Ahmed, Awais; Moss, Alan C.

doi:10.1586/eci.10.22

Cited by 10 publications

(7 citation statements)

References 34 publications

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“…The first OD mesalamine preparation (Apriso; Salix Pharmaceuticals, NC, USA) was approved by the U.S. Food and Drug Administration (FDA) for the maintenance of UC remission 18 . To date, the OD administration of various proprietary forms of 5‐ASA has been proven safe and effective in contemporary clinical trials, 19 and many clinicians have applied this more practical dosing scheme to delayed and sustained release formulations of oral mesalamine.…”

Section: Discussionmentioning

confidence: 99%

“…The first OD mesalamine preparation (Apriso; Salix Pharmaceuticals, NC, USA) was approved by the U.S. Food and Drug Administration (FDA) for the mainte-nance of UC remission. 18 To date, the OD administration of various proprietary forms of 5-ASA has been proven safe and effective in contemporary clinical trials, 19 and many clinicians have applied this more practical dosing scheme to delayed and sustained release formulations of oral mesalamine. A pharmacokinetic data analysis by Gandia et al 20 also showed that concentrations of 5-ASA and acetylated 5-ASA (Ac-5-ASA) in urinary and fecal excretion and rectal tissue were similar following single or divided daily dosing in 30 healthy volunteers.…”

Section: Discussionmentioning

confidence: 99%

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Once‐daily versus multiple‐daily mesalamine for patients with ulcerative colitis: A meta‐analysis

Jin

Huang²,

Xu³

et al. 2012

J of Digest Diseases

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OBJECTIVE:To systematically review the efficacy and safety of once-daily (OD) mesalamine for the treatment of ulcerative colitis (UC) compared with multiple-daily (MD) mesalamine. METHODS:Electronic databases up to July 2011 were searched for related studies evaluating the efficacy of OD vs MD for treatment of UC. Only randomized controlled trials (RCTs) were considered eligible. Remission rates or relapse rates were analyzed using intention-to-treat (ITT) and per-protocol (PP) analysis. Pooled relative risk (RR) and 95% confidence interval (CI) were calculated. Publication bias was assessed with a funnel plot. RESULTS:Overall 10 RCTs including 9 full-text manuscripts and one abstract met the inclusion criteria. OD dosing of mesalamine was shown to be as effective as MD dosing for the maintenance of clinical remission in patients with quiescent UC (RR = 1.00, 95% CI 0.89-1.12) by ITT analysis. For active UC, a mild but significant benefit was achieved by OD dosing compared with MD dosing (RR = 0.80, 95% CI 0.64-0.99). Total adverse events were similar using OD and MD mesalamine in quiescent UC (RR = 1.06, 95% CI 0.93-1.20). Compliance with OD was slightly better than with MD (RR = 0.92, 95% CI 0.82-1.03). CONCLUSIONS:OD mesalamine is as effective and has a comparable safety profile as MD regimens for the maintenance treatment of UC, and is even more effective for inducing remission in active UC.

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Section: Discussionmentioning

confidence: 99%

Section: Discussionmentioning

confidence: 99%

Once‐daily versus multiple‐daily mesalamine for patients with ulcerative colitis: A meta‐analysis

Jin

Huang²,

Xu³

et al. 2012

J of Digest Diseases

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“…Lialda/Mezavant capsules contain additional lipophilic and hydrophilic matrices Multi Matrix System (MMX) within the Eudragit S capsule, with the goal of allowing slower diffusion of the drug through the colon [25]. Apriso also contains a polymer matrix coated with Eudragit L, designed to gradually distribute mesalamine throughout the colon [26]. …”

Section: Pharmacologymentioning

confidence: 99%

“…At 1-year follow-up, 54% of patients on Pentasa were in continued remission as opposed to 46% of patients on sulfa-salazine [45]. Maintenance studies of Apriso reported that 78.9% of patients on Apriso maintained remission compared with 58.3% of the placebo group [26]. The US FDA-approved doses for maintaining remission are as follows: Asacol 1.6 g daily; Lialda 2.4 g daily; and Apriso 1.5 g daily.…”

Section: Clinical Efficacymentioning

confidence: 99%

Mesalamine in the treatment and maintenance of remission of ulcerative colitis

Ham

Moss²

2012

Expert Review of Clinical Pharmacology

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128

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Ulcerative colitis (UC) is a chronic disease of the GI tract that is characterized by mucosal inflammation in the colon. Mesalamine (mesalazine) is a 5-aminosalicylic acid compound that is the first-line treatment for patients with mild-to-moderate UC. There are multiple formulations of mesalamine available, primarily differentiated by their means of delivering active mesalamine to the colon. Mesalamine has been demonstrated in randomized controlled trials to induce both clinical response and remission, and maintain clinical remission, in these patients. It has few serious adverse effects and is generally well tolerated by patients. The main areas of uncertainty with use of mesalamine in patients with UC center on the optimal dose for induction of response, how to maintain patient adherence and the role of mesalamine in cancer chemoprophylaxis. Generic forms of mesalamine have yet to be approved by regulatory bodies in the USA.

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“…There is also a disconnect between the “FDA‐approved” indications and dosing of these drugs and their use in clinical practice. Only Asacol (Warner‐Chilcott) and Apriso (Salix) have been approved for maintenance of remission in UC, whereas Asacol HD (Warner‐Chilcott) is only approved for 6 weeks use for induction of remission; despite this, all these agents are used long‐term for maintenance of remission in practice 33, 34…”

Section: Current Fda‐approved Therapies For Ibdmentioning

confidence: 99%

Drug development in inflammatory bowel disease: The role of the FDA

Lahiff

Kane

Moss

2011

Inflammatory Bowel Diseases

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All medicinal compounds sold in the United States for inflammatory bowel disease (IBD) are regulated by the Food and Drug Administration (FDA) via a number of regulations dating back to 1906. The primary contemporary role of the FDA is in the assessment of safety and efficacy, and subsequent marketing, of medications based on preclinical and clinical trial data provided by sponsors. This includes pharmacokinetic, toxicology and clinical studies, and postapproval safety monitoring. Mesalamine formulations, budesonide, and biologic therapies have all been assessed for efficacy and safety in IBD by the FDA via large randomized controlled trials (RCTs). There has been considerable evolution in the endpoints used by the FDA to approve medications for IBD, and the mechanisms through which newer agents have been approved. This review examines the methods of drug approval by the FDA, the bench-marks used to approve drugs for IBD, and recent controversies in the FDA's role in drug approval in general.

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Once-daily mesalamine granules for ulcerative colitis

Cited by 10 publications

References 34 publications

Once‐daily versus multiple‐daily mesalamine for patients with ulcerative colitis: A meta‐analysis

Once‐daily versus multiple‐daily mesalamine for patients with ulcerative colitis: A meta‐analysis

Mesalamine in the treatment and maintenance of remission of ulcerative colitis

Drug development in inflammatory bowel disease: The role of the FDA

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