MacroChem Corporation announced that preliminary data from its Phase 2 pharmacodynamic study of Topiglan, a topical cream for erectile dysfunction, demonstrate that Topiglan did not meet the study's primary clinical endpoints. The randomized, double-blind clinical study, which utilized the RigiScan monitoring technique, compared the efficacy of Topiglan in men with mild-to- moderate erectile dysfunction to a placebo cream.
"While we are disappointed by these preliminary Topiglan data, we continue to advance our clinical studies of EcoNail and Opterone," said Robert J. DeLuccia, chief executive officer of MacroChem. "We plan in the weeks ahead to further analyze all of the Topiglan study data."
MacroChem currently has two other clinical programs underway. A dose- proportionality study of Opterone cream, an absorption-enhanced topical treatment for male testosterone deficiency, is ongoing. Patients are currently being dosed and results from that study are expected later this year. The Company has also initiated a Phase 1 study of EcoNail in patients with onychomycosis, a fungal infection of nails. Patient screening is nearly complete and data from this study are expected to be available by the end of the year.
MacroChem is a specialty pharmaceutical company that innovates, develops and commercializes pharmaceuticals administered in novel ways, to treat important medical conditions.