Data was announced today that demonstrated Salix Pharmaceuticals’ (NASDAQ:SLXP) APRISO™ (mesalamine) 0.375g extended-release capsules had a favorable safety profile in patients in remission from ulcerative colitis (UC) for up to 24 months. APRISO is approved for use up to six months. The majority of treatment-emergent adverse events were mild or moderate in intensity, and were similar to what was seen during the 6-month phase 3 trials. The study, which is the first to examine the long-term safety profile of APRISO, was presented at the Digestive Disease Week (DDW) annual meeting in Chicago, Illinois.

“It is important to provide UC patients with a new treatment option that can be safely used over the long-term,” said Dr. Glenn L. Gordon, Medical Director and President of the Center for Digestive and Liver Diseases, Inc. in Mexico, Missouri. “The favorable long-term safety profile of APRISO, combined with once-daily dosing, may support its use as first-line therapy for long-term* maintenance of UC remission.”

Patients with UC may experience periods of remission (times when the symptoms go away) that can last for months or years. Maintenance therapy refers to treatment given to patients to enable them to stay in remission, and to maintain their health in a disease-free, or limited-disease, state. UC is a lifelong disease; therefore, maintenance medications must usually be taken for a prolonged period of time.

The Long-Term Safety Analysis

Safety data for this analysis included 557 patients in remission from UC who were treated with APRISO in a long-term, open-label extension trial, with 250 patients exposed to APRISO for greater than one year, of which 137 patients were exposed for over 18 months. Patients included in this long-term safety analysis were either new, or had rolled over from two randomized, double-blind, placebo-controlled, phase 3 trials. The majority of treatment-emergent adverse events were mild or moderate in intensity, and were similar to what was seen during the 6-month phase 3 trials. Overall, long-term compliance with APRISO was high, with an average compliance of 90 percent in the safety analysis population.

Additional Abstracts Presented at DDW Further Support the Safety and Efficacy of APRISO for the Maintenance of Remission of UC.

Poster #T1202

Two phase 3 studies (n=562) showed that a significantly greater proportion of patients receiving once-daily APRISO (1.5 g) remained relapse-free after six months of treatment, compared to placebo (79 percent vs. 62 percent [P<0.001]). Further, those treated with APRISO maintained remission of UC symptoms with noticeable improvement as early as one month after initiation.