A New Oral Delivery System for 5-ASA: Preliminary Clinical Findings for MMX

Abstract

Preliminary studies suggest that similar rates for induction of remission can be expected from 5-ASA enemas and MMx for patients with left-sided ulcerative colitis.

Long‐term oral mesalazine adherence and the risk of disease flare in ulcerative colitis: nationwide 10‐year retrospective cohort from the veterans affairs healthcare system

“…29,30 A simplified drug delivery system and less intrusive dosing is another important factor that has been investigated. 31,32 Scheduling frequent follow-up visits at 2 weeks, 3 months and then each 6 months after the initiation, if prescribing mesalazine therapy 8,33 may aid in increasing adherence. During these visits, routine pill checks can be very helpful through asking the patient to bring in his medication to be inspected by the physician to assess the extent of home utilisation.…”

Discussion About Treatment of Ulcerative Colitis.

“…Novel delivery systems and higher dosing formulations of 5-ASA are also in development. These include the once-daily oral multimatrix (MMx) 5-ASA (SPD476) formulation [34,35] ; a twice-daily oral micropellet formulation [36] ; a once-daily, slow-release suppository formulation [37] ; and a 5-ASA rectal gel that treats the left colon and in early trials is preferred by patients over existing 5-ASA enema preparations. [38,39] A new MMx formulation of mesalamine (SPD476; MMX mesalamine) [40,41] is now undergoing clinical trials.…”

“…As the hydrophilic matrix erodes, the 5-ASA diffuses out of the lipophilic matrix, providing even drug distribution from the ascending colon to the rectum. Prantera and colleagues [34] conducted an 8-week doubledummy study involving 79 patients with left-sided colitis; subjects received either 1.2 g SPD476 3 times daily or a 4-g mesalamine enema. There were similar rates of clinical and endoscopic remission for patients treated with SPD476 and mesalamine enema.…”

Use of new once-daily 5-aminosalicylic acid preparations in the treatment of ulcerative colitis: Is there anything new under the sun?

“…First, a preliminary randomized, double-blind, doubledummy clinical study compared the efficacy of MMX mesalazine versus topical mesalazine in 79 patients with active, left-sided, mild-to-moderate UC [13] . Comparable clinical remission rates were achieved; 60% of the patients in the MMX mesalazine group and 50% of the patients in the enema group were in clinical remission at the end of week eight.…”

“…Of the 434 MMX mesalazine recipients evaluated for safety in the four published controlled trials [13][14][15][16][17][18][19][20][21] , only two patients had serious adverse events that were considered treatment-related; both included pancreatitis caused by hypersensitivity to mesalazine. There was no evidence of a dose-response relationship with MMX mesalazine for any tolerability parameter in either trial.…”