Main > UROLOGY > Erectile Dysfunction > Treatment. > MelanoCortin Agonists. (on CNS) > Co.: USA. P (Development/Patents) > Development Status: Phase II

Product USA. P

STATUS has been evaluated in four Phase 2 efficacy studies enrolling more than 300 men. Phase 2 data was presented at the American Urological Association meeting in May 2003. Data from the Phase 2 at-home study was presented at the 8th Annual Leadership Conference on Sexual, Cardiovascular and Metabolic Syndrome Related Therapies in November 2003. The Company plans to begin Phase 3 trials in men in late 2006.

Key Clinical Findings from Phase 2 Studies:

effective in a broad range of patients, including those with severe ED and those non-responsive to sildenafil
efficacy in at-home studies is comparable to PDE-5 inhibitors
up to 50% of ED patients were restored to a normal level of function
co-administration with sildenafil shows superior efficacy
side effects included:
facial flushing
nausea
aftertaste
post-nasal drip

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