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January 22, 2007
MediciNova reported negative results from a phase II/III trial of MN-001 for the treatment of interstitial cystitis (IC). This randomized, double-blind, placebo-controlled trial enrolled 305 subjects with moderate to severe IC. Treatment was well tolerated. Statistical significance over placebo was not seen in the primary endpoint, overall improvement on a patient-rated Global Response Assessment at a dose of 500mg once or twice a day for 8 weeks. Results indicated that after four weeks of treatment, 25% of the subjects were likely to respond versus 12% on placebo (p=0.04). However, after eight weeks of treatment response rates between the groups did not differ due to continued improvement of the placebo group. Due to these results, MediciNova planned to discontinue development of MN-001 for IC and focus on asthma related disorders.
Wastson announced positive results from two phase III trials of silodosin for the treatment of benign prostatic hyperplasia (BPH). These double-blind, placebo-controlled trials enrolled 1,200 subjects in the US who received 8mg silodosin or placebo once daily for 12 weeks. Treatment was well tolerated with adverse events, including cardiovascular and blood pressure related effects, mild to moderate in nature. The primary endpoint, relief of BPH symptoms as measured by a baseline-to-endpoint change in the total score of the International Prostate Symptom Score-1 (IPSS-1) and the secondary endpoint, improvement in maximum urine flow, were achieved with statistically significant improvements observed for both objectives. Based on these results, Watson plans to file a NDA with the FDA in the first half of 2008.
August 25, 2003
Bioniche Life Sciences reported negative preliminary results from a clinical trial investigating Cystistat (sodium hyaluronate), a hyaluronic acid solution for the treatment of interstitial cystitis. Result showed the subjects’ responses were satisfactory in the Cystistat cohort (>50) but were not statistically different compared with placebo. The primary endpoint of response was defined by patient global satisfaction and pain reduction at week eight. The double blind, randomized, placebo-controlled trial evaluated 138 interstitial cystitis subjects at 17 sites across the U.S. and Canada. Subjects who were 18 years-of-age or older and diagnosed with interstitial cystitis according to National Institute of Diabetes and Digestive and Kidney Diseases criteria were eligible for the study.
August 18, 2003
The Interstitial Cystitis Clinical Trials Group reported negative results from a pilot study investigating the combination Elmiron (pentosan) and Atarax (hdroxyzine) for the treatment of interstitial cystitis (IC). Results showed that neither of the drugs nor the combination therapy produced statistically significant benefits. The 18-month, randomized, placebo controlled study enrolled 121 patients with IC. Subjects received Elmiron or Atarax, a combination of the two, or a placebo. The primary end point was a global response assessment reported by the subject. Secondary end points included validated symptom indexes and reports of pain, urgency and frequency. Results were reported in the September issue of the Journal of Urology. Due to the lack of significant results, the group does not plan to expand these trials.