Diseases and Products | Insomnia
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Disease Overview:
Insomnia is characterized by difficulty falling asleep (i.e., sleep onset or sleep induction), difficulty in staying asleep (i.e., sleep maintenance), early final awakening (i.e., sleep maintenance), or non-restorative sleep. The National Institutes of Health indicates that more than 70 million Americans are affected by insomnia.
MN-305 for the Treatment of Insomnia:
We analyzed the results from our Phase II/III clinical trial of MN-305 in Generalized Anxiety Disorder and performed in-depth analyses of subgroups that showed statistically significant improvement in certain aspects of the HAM-A score (e.g., insomnia). Based on these analyses, we initiated a Phase IIa proof-of-concept clinical trial of MN-305 for the treatment of insomnia in the first quarter of 2007 to assess the effects of three dosages of MN-305 (1 mg, 3 mg and 6 mg) and placebo, all administered orally approximately 60 minutes before bedtime. This clinical trial, which involved 74 subjects at ten study centers in the United States, was completed in the fourth quarter of 2007. This clinical trial failed to achieve statistical significance in its primary endpoint of reducing Wake (time) After Sleep Onset, or WASO. MN-305 was well tolerated in this clinical trial with no clinically significant adverse events observed at any dose tested, and there was no evidence of any decrements in psychomotor performance, as assessed in digit symbol substitution and symbol copying tests, in patients treated with MN-305.
Based upon the results of the Phase IIa clinical trial of MN-305 for the treatment of insomnia, we decided to terminate the evaluation of MN-305 in insomnia and focus on the development of MN-305 for the treatment of psychiatric disorders, specifically Generalized Anxiety Disorder.
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