May 21, 2012
Ventrus Biosciences issued results from a phase III trial of VEN 307 (diltiazem hydrochloride cream) for the treatment of anal fissures. This randomized, double-blind, placebo-controlled study enrolled 465 patients. Subjects received VEN 307 2% or 4% or placebo, applied topically three times daily (TID) for eight weeks, followed by a four-week blinded observation period. The study met its primary endpoint, with both 2% and 4% VEN 307 treatment arms demonstrating significant improvements compared to placebo in the average of worst anal pain associated with or following defecation, with a pain score improvement of 0.43 for 2% (p≡0.0134) and 0.44 for 4% (p≡0.0108). The most common adverse events in all three arms (including placebo) were headaches and gastrointestinal disorders. Based on these data, Ventrus will request a meeting with the FDA to discuss a phase III study of VEN 307 and move forward on a New Drug Application.
February 2, 2004
Cellegy Pharmaceuticals reported preliminary results of a phase III trial investigating Cellegesic (nitroglycerin .4%), an ointment for the treatment of chronic anal fissures. Results showed the drug produced a statistically significant reduction in anal fissure pain compared with placebo, the primary efficacy endpoint of the study. Data showed that the time to 50% pain reduction with Cellegesic was a week sooner than with placebo, although not statistically significant. No significant difference was seen in tertiary endpoints, reduction of average pain over the eight-week and reduction of pain upon defecation through days 21 and 56, and healing. Most common side effects were mild to moderate headaches. The double blind, placebo controlled trial enrolled 187 subjects with chronic anal fissures.
Elan and Biogen reported positive results from a phase III trial investigating Antegren (natalizumab), a humanized monoclonal antibody for the treatment of Crohn’s disease. Results showed that the study met the primary endpoint of maintenance of response, defined by a sustained Crohn's Disease Activity Index (CDAI) score of less than 220 without rescue intervention. Data showed more than a 30% difference in treatment with natalizumab compared to placebo. The double-blind, placebo-controlled, international maintenance trial, called ENACT-2 (Evaluation of Natalizumab as Continuous Therapy-2) enrolled 428 responders from ENACT-1 (a 3-month study in patients with very active Crohn's disease). Subjects were re-randomized after 3 months to natalizumab (300 mg) or placebo administered monthly for 12 months. The primary endpoint was through month 6 of ENACT-2.