Premenstrual Syndrome

January 15, 2007

Neurocrine released positive preliminary results from a phase II trial of NBI-56418 for the treatment of endometriosis. This multi-center, randomized, double-blind, placebo-controlled trial enrolled 68 subjects who were randomized to one of three treatment groups: 50 mg or 100 mg of NBI-56418 or placebo, each administered twice daily. Treatment started on day 2 to day 7 of the menstrual cycle and continued over 12 weeks, with assessments of symptoms and signs of disease conducted at 4-week intervals. The primary endpoint, reduction in endometriosis symptoms, was evaluated using the Composite Pelvic Sign and Symptoms Score (CPSSS) and the Visual Analog Scale (VAS) measured pain intensity. Treatment was well tolerated, with adverse events similar across the groups. CPSSS, with a maximum value of 15, displayed mean values at baseline of 7.8 (placebo), 7.2 (50 mg) and 8.3 (100mg). After treatment there were reductions of 4.3 (placebo), 4.7 (50 mg) and 5.3 (100 mg) points in the score at week 12. The VAS scores at baseline were 73 (placebo), 68 (50 mg) and 72 (100 mg). Data revealed dose-related improvements in the maximum score, particularly at week 4 with reductions of 3 (placebo), 17 (50 mg) and 20 (100 mg). Based on the data, Neurocrine plans move the development of NBI-56418 forward.

Pherin revealed positive results from a phase II trial of intranasal PH80 for the treatment of Premenstrual Syndrome. This double blind, placebo-controlled trial enrolled 60 subjects who were randomized into one of two treatment groups: 800 nanograms of PH80 up to four times daily during six consecutive days or placebo. Treatment was well tolerated, with no reported adverse events. The primary endpoint, statistically significant improvement in PMS symptoms compared to placebo, was met, with 63% of the PH80 treated subjects showing an improvement versus 44% on placebo (p less than 0.05). Remission of symptoms one month after treatment also showed statistically significant improvement when compared to placebo (p less than 0.01) . Based on these results, Pherin was planning phase III trials to further evaluate PH80 in the treatment of Premenstrual Syndrome.