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TorreyPines Therapeutics Muscarinic Agonist NGX267 Meets Primary Endpoint in a Phase II Clinical Trial in Patients with Xerostomia
Date:12/2/2008

or new therapies that could offer patients less frequent dosing regimens and better tolerability."

The randomized, double-blind, placebo-controlled, in-clinic trial used a cross-over design to evaluate the efficacy, safety and tolerability of three doses of NGX267. A total of 26 patients with xerostomia associated with primary or secondary Sjogren's syndrome were enrolled at three sites in the United States. In four distinct treatment periods, each patient was randomized to receive a single dose of 10 mg, 15 mg and 20 mg of NGX267 and placebo. Patients remained in the clinic and serial efficacy assessments were taken at scheduled time points through 24 hours post dosing. For the primary endpoint, whole mouth salivary flow was collected by passive drainage into pre-weighed containers. Secondary endpoints included maximum change in salivary flow rate compared to predose and an 8-item salivary flow questionnaire completed by the patient that assessed the impact of dry mouth across various dimensions of patient functioning.

The 10 mg, 15 mg and 20 mg doses of NGX267 produced statistically significant increases in salivary flow compared to placebo across a number of time points, including the mean salivary flow production over the 24 hour post-dosing period (p=0.025, 0.001, and 0.001, respectively). In addition, the maximum change in salivary flow was statistically significant compared to placebo for each of the three doses of NGX267. Results of the 8-item patient self-assessment correlated with the quantitative results of salivary production. At the 15 mg and 20 mg doses, statistically significant differences compared to placebo were demonstrated in a variety of domains including items that rated improvement in speaking and swallowing, dryness of mouth and level of thirst.

Safety was monitored throughout the evaluation period and NGX267 was shown to be safe and well-tolerated. All patients completed all tr
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SOURCE TorreyPines Therapeutics, Inc.
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