Shire plc (LSE: SHP, NASDAQ: SHPGY, TSX: SHQ), the global specialty biopharmaceutical company, today announced the availability in Canada of Mezavant(R)* (mesalamine delayed and extended release tablets) with Multi Matrix System (MMX(TM)(xx)) Technology, indicated for the induction of clinical and endoscopic remission in patients with active, mild to moderate ulcerative colitis (UC), a type of inflammatory bowel disease. Mezavant is the first and only Health Canada approved once-daily oral formulation of mesalamine, and the first mesalamine to be approved by Health Canada for the induction of clinical and endoscopic remission.
MEZAVANT is the only ulcerative colitis treatment that utilizes MMX Technology, which combines a pH dependent gastro-resistant coating, thus delaying and extending the delivery of effective concentrations of mesalamine to the site of inflammation in the colon over an extended period of time (from six hours after dosing to beyond 24 hours post-dose). It is available by prescription for oral administration in dosages of 2.4g/day to 4.8g/day, allowing patients to take as few as two tablets, once-daily. Other currently available mesalamines require two to four times daily dosing and up to eight pills a day.
In a chronic, life-long disease such as ulcerative colitis, complex therapy regimens make it difficult for a patient to strictly adhere to therapy, often leading to non-compliance. Two North American Internet surveys(1) conducted with ulcerative colitis patients (n equals 451) and gastroenterologists (n equals 300) reflected this difficulty of adherence with current 5-ASA therapy. Both patients and gastroenterologists reported that managing UC medication is a struggle for patients (49 per cent and 41 per cent respectively) and that it is difficult for patients to take medication as prescribed every day (42 per cent and 90 per cent respectively). This difficulty is further exemplified by the fact that 46 per cent of patients reported not taking all of their medication in the past week.
"The more complicated and varied a dosing regimen is for a patient, the less likely they are to strictly adhere to it, leading to reduced efficacy and ultimately sub-par disease control and low quality of life," states Dr. A. Hillary Steinhart, Head, Combined Division of Gastroenterology, Mt. Sinai Hospital and the University Health Network, Toronto, Ontario. "The availability of Mezavant, with its convenient once-daily dosing, will go a long way in helping address the compliance issues facing Canadian ulcerative colitis patients, allowing them to overcome the disruptions to their life that can be caused by their disease."
"Although not everyone's experience is the same, my complicated pill schedule seems to consume my life - my next dosage is constantly on my mind, and I still occasionally forget a dose" says James Mireau, an ulcerative colitis patient from Edmonton, Alberta. "I have enough to concern myself with due to my disease; taking my pills once-a-day will certainly make my life easier by allowing me the freedom to focus on the more important things, like family." The approval of MEZAVANT was based on the results of two, three-armed, Phase III clinical studies comparing the efficacy of MEZAVANT 2.4g/day, 4.8g/day and placebo after eight weeks of treatment. The primary efficacy endpoint in both trials was based on a composite endpoint indicative of clinical remission and mucosal healing, the first time a mesalamine trial has included both. Remission was defined as a modified Ulcerative Colitis Disease Activity Index (UC-DAI) score of less than 1.
The first study(2) assessed the efficacy and safety of MEZAVANT at 2.4g/day given in divided doses twice-daily and at 4.8g/day given once-daily against placebo (n equals 262). At eight weeks, both doses demonstrated statistically significant superiority over placebo in the induction of remission. The second study(3) assessed the efficacy and safety of MEZAVANT 2.4g/day and 4.8g/day, both given once-daily versus placebo (n equals 255). At eight weeks, both once-daily doses demonstrated statistically significant superiority over placebo in the induction of remission. "Effective, safe and convenient therapy options are imperative for gastroenterologists treating ulcerative colitis. Based on the results from its clinical trials, Mezavant will be a welcome addition to our armamentarium to help induce remission in ulcerative colitis patients," adds Dr. Steinhart.
Important Safety Information
MEZAVANT is generally well tolerated. The majority of adverse events in the double-blind, placebo-controlled trials were mild or moderate. In clinical trials (n equals 535), the most common treatment-related adverse events with MEZAVANT were headache and flatulence.
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