Shire plc today announced the availability of LIALDATM (mesalamine) with MMXTM Technology, indicated for the induction of remission in patients with active, mild to moderate ulcerative colitis (UC), a type of inflammatory bowel disease. LIALDA is the first and only FDA-approved once daily oral formulation of mesalamine. The US Food and Drug Administration approved LIALDA on Jan. 16, 2007.
LIALDA is available to patients by prescription for oral administration in dosages of 2.4 g/day and 4.8 g/day, allowing patients to take as few as two tablets once daily. Other currently available mesalamines require three to four times daily dosing and six to 16 pills a day. A study found that patients who are not compliant with their mesalamine medications have a five-fold greater risk of disease flares, a serious worsening of symptoms, than compliant patients.
“In clinical trials, LIALDA was superior to placebo in inducing remission. Additionally, LIALDA’s convenient once daily dosing may help address the compliance issues facing so many ulcerative colitis patients,” said Mike Cola, President of Shire’s Specialty Pharmaceuticals business. “Shire is pleased to offer this latest advancement in the treatment of ulcerative colitis, which complements our existing GI portfolio and reinforces our commitment to improving the treatment of gastrointestinal diseases.”
“Although not everyone’s experience is the same, taking the pills for my disease seemed to consume my life – my next dosage was constantly on my mind,” said Becky Pace, a LIALDA clinical trial patient. “I could not believe taking medication once a day would help as much as it did. LIALDA brought my disease into remission.”
About LIALDA
LIALDA is part of a drug class called aminosalicylates, which contain 5-aminosalicyclic acid (5-ASA). 5-ASA is a well-established drug of choice and often a first-line treatment for UC. LIALDA is indicated for the induction of remission in patients with active, mild to moderate UC. LIALDA is the first new formulation in this class to be approved since 2000. The safety and efficacy of LIALDA has been established for up to eight weeks. LIALDA is the only ulcerative colitis treatment that utilizes MMX Technology. LIALDA with MMX Technology combines a pH dependent gastro-resistant coating, which delays the release of the medication to the colon (the site of the inflammation in ulcerative colitis), with a tablet core containing mesalamine with hydrophilic and lipophilic excipients.
Shire has licensed from Giuliani SpA the exclusive rights to develop and commercialize LIALDA in the U.S., Canada, Europe — known as MEZAVANT? — (excluding Italy) and the Pacific Rim. Giuliani SpA retains the development and commercialization rights in Italy. Cosmo Pharmaceuticals SpA, Milan, developed the MMX technology.
LIALDA Effectively Induces Remission
The approval of LIALDA was based on the results of two Phase III clinical studies. The first study assessed the efficacy and safety of LIALDA 2.4 g/day given in divided doses twice daily and 4.8 g/day given once daily against placebo in 262 patients. At eight weeks, both doses demonstrated superiority over placebo in the induction of remission (34.1 percent with 2.4 g/day, 29.2 percent with 4.8 g/day, and 12.9 percent with placebo). These study results were recently published in the January 2007 issue of Clinical Gastroenterology and Hepatology.
The second study assessed the efficacy and safety of LIALDA 2.4g/day and 4.8g/day (both given once daily) against placebo in 255 patients. At eight weeks, both once daily doses demonstrated superiority over placebo in the induction of remission (40.5 percent with 2.4 g/day, 41.2 percent with 4.8 g/day, and 22.1 percent with placebo). These study results were published in the January 2007 issue of Gastroenterology.
Important Safety Information
LIALDA tablets are indicated for the induction of remission in patients with active, mild to moderate ulcerative colitis. Safety and effectiveness of LIALDA beyond eight weeks have not been established.
LIALDA is contraindicated in patients with hypersensitivity to salicylates (including mesalamine) or to any of the components of LIALDA. Caution should be exercised when treating patients with pyloric stenosis or those allergic to sulfasalazine. Mesalamine has been associated with an acute intolerance syndrome (three percent of patients in clinical trials with mesalamine or sulfasalazine) that may be difficult to distinguish from a flare of inflammatory bowel disease. Symptoms include cramping, acute abdominal pain and bloody diarrhea, and sometimes fever, headache and rash. If acute intolerance syndrome is suspected, prompt withdrawal is required. Mesalamine-induced cardiac hypersensitivity reactions (myocarditis and pericarditis) have been reported. Reports of renal impairment have been associated with mesalamine medications. Caution should be exercised, and LIALDA should be used only if the benefits outweigh the risks. No information is available for patients with hepatic impairment; therefore caution is recommended.
LIALDA is generally well tolerated. The majority of adverse events in the double-blind, placebo-controlled trials were mild or moderate in severity. In clinical trials (N=535), the most common treatment-related adverse events with LIALDA 2.4g/day, 4.8g/day and placebo were headache (5.6 percent, 3.4 percent and 0.6 percent, respectively) and flatulence (four percent, 2.8 percent and 2.8 percent, respectively). Pancreatitis occurred in less than one percent of patients during clinical trials, and resulted in discontinuation of therapy with LIALDA.