ASACOL HD (Mesalamine) 800mg delayed-release tablets from Procter & Gamble
Asacol HD (mesalamine delayed-release tablets, from Procter & Gamble) has been made available for the treatment of moderately active ulcerative colitis (UC). Asacol HD was approved by the FDA based on results from the ASCEND studies (Assessing the Safety and Clinical Efficacy of a New Dose of 5-ASA). The primary endpoint of the ASCEND II and III studies was overall improvement at six weeks, determined by the Physician's Global Assessment which encompassed the clinical assessments of rectal bleeding, stool frequency, and sigmoidoscopy findings. At six weeks, 72% and 70% of patients treated with Asacol HD achieved overall improvement compared to 59% and 66% of patients treated with Asacol in the ASCEND II and ASCEND III studies, respectively. Additionally, Asacol HD demonstrated improvement in rectal bleeding in 75% and 78% of patients at three weeks and 79% and 84% of patients at six weeks in the ASCEND II and ASCEND III studies, respectively. Improvement in stool frequency was achieved in 64% and 76% of patients at three weeks and 74% and 79% of patients at six weeks in the ASCEND II and ASCEND III studies, respectively.
Asacol HD is available in a 800mg dosage strength.