Macrochem Corporation Announces Preliminary Phase IIB Results With Topiglan Gel
December 17, 1998 12:42 PM
LEXINGTON, Mass., Dec. 17 /PRNewswire/ -- MacroChem Corporation (NASDAQ: MCHM) announced today a preliminary review of a Phase IIB study of its topical gel, Topiglan, a proprietary topical formulation of alprostadil, in the treatment of erectile dysfunction. The study was carried out by Dr. Irwin Goldstein of the Department of Urology at Boston University Medical Center.
The study was double-blind (i.e., neither the patient nor the investigator nor MacroChem knew any patient's treatment), randomized, placebo-controlled (i.e., assignment to the Topiglan or placebo group was by chance, with half the subjects receiving 0.25 ml 1% alprostadil in a SEPA -formulated gel, and the other half a SEPA-formulated gel without alprostadil) in an office setting with visual and tactile stimulation. Sixty patients with documented erectile dysfunction, were treated with either Topiglan or placebo, applied topically to the head of the penis. Many of the patients had previously failed to respond to available therapies, including Viagra, MUSE and surgical revascularization.
Topiglan application was associated with statistically greater penile rigidity and tumescence (p=0.033) compared to placebo, as assessed by the physician. This was confirmed by the patient's assessment in which Topiglan was also rated as significantly better than placebo (p=0.003). In fact, six times more patients stated that the erection attained following Topiglan application was sufficient for vaginal intercourse compared to placebo-treated patients (p=0.005). Treatment was accompanied by transient, minor to mild symptoms of localized warmth, occasionally minor to mild burning or tingling in some patients, with no difference observed between Topiglan and placebo treatments.
There were no significant changes in vital signs in any patient in either group.
Dr. Goldstein commented: "These data demonstrate that Topiglan applied topically to the glans of the penis is effective to increase penile rigidity in patients with significant erectile dysfunction, with the result that an increased number of these individuals attained erections judged adequate for vaginal penetration."
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