Stomach Discomfort

April 21, 2008

Napo and Glenmark released positive results from a phase II trial of crofelemer for the treatment of acute infectious diarrhea. This randomized, parallel group, double-blind, placebo-controlled study enrolled ninety-eight adult subjects in India. All subjects had experienced acute diarrhea, defined as the occurrence of three or more unformed stools (soft or watery consistency) within the twenty four hour period preceding entry into the study. The subjects received 250 mg of crofelemer four times per day until recovery or for a maximum of three days. The primary endpoint was improvement in gastrointestinal symptoms, including stool weight, stool frequency, stool consistency and duration of diarrhea. These were recorded by the investigators at baseline, and days one, two and three of treatment. Statistically significant improvements were reached in all the primary endpoints. Overall clinical success was achieved in 79.1% of the evaluable subjects receiving crofelemer compared to 28.2% of the evaluable subjects receiving placebo. Crofelemer was well tolerated and most adverse events were mild to moderate in severity and not different from the placebo group. Based on the results the companies plan to begin another dose-ranging trial in 2008, investigating lower doses and lower dosing frequency.

July 9, 2007

Cosmo reported positive preliminary results from a phase II/III trial of Rifamycin for the treatment of infectious diarrhea. This placebo controlled, randomized, double blind trial enrolled 120 subjects in South Africa. Subjects were treated with Rifamycin or Normix (rifaximin), the standard of care, administered as a 200 mg tablet, 4 times per day for 3 days. The primary endpoint was to establish non-inferiority between the two treatments and the time from first ingestion of tablet to the last unformed stool. Initial data suggest that this was achieved. Cosmo plans to further analyze the results and move forward with the development of Rifamycin.

October 3, 2005

AP Pharma has reported positive results of a phase II trial of their investigational anti-emetic APF530, for the treatment and prevention of nausea and vomiting associated with chemotherapy. Safety data yielded no evidence of serious adverse events and a positive overall tolerability profile. Pharmacokinetic data established dose- proportional plasma levels, time to maximum concentration and overall expose, and supported use of a single subcutaneous dose of the drug 30 minutes prior to initiation of chemotherapy. Single subcutaneous doses provided sustained plasma exposure over time, of a duration suitable for treating both acute (day 1) and delayed (days 2-7) emetic symptoms. Efficacy data, measuring the number of emetic episodes, use of rescue medication, and the degree of daily patient-reported nausea, yielded positive results in both the acute: better than 90% of subjects in the lower 2 dosing groups and slightly less than 80% of subjects in the high dose group were acute-phase complete responders (no emetic episodes, no rescue medication), and in the delayed phase, complete response rates were better than 90%, better than 80%, and just under 70% for the low, middle and high dose groups, respectively. This open-label, dose-ascending study enrolled 45 chemotherapy patients, who received one of 3 single subcutaneous doses of the drug (5, 10 or 15 mg) prior to chemotherapy followed by a 7 day observational follow-up.

April 22, 2002

Preliminary analysis of phase III trial results indicate that palonosetron, a 5-HT3-receptor antagonist for chemotherapy-induced nausea and vomiting, met the targeted efficacy endpoints. Additionally, an analysis assessing the complete response rate for the 24-120 hour time period favored palonosetron over comparator agents. The phase III program compared palonosetron to currently marketed 5-HT3-antagonists and included over 130 medical centers in North America and Europe. Subjects received single intravenous doses of palonosetron or a comparator prior to treatment with moderately or highly emetogenic chemotherapy. The primary efficacy endpoint was the acute complete response rate, which was defined as the percentage of subjects who did not experience vomiting or receive rescue medication in the 24-hour period after receiving chemotherapy. Palonosetron is being developed by Helsinn Healthcare and MGI Pharma.

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