MacroChem Gel Effective on Impotence, Two New Studies Suggest
Amsterdam, Aug. 27 (Bloomberg) - MacroChem Corp. said its Topiglan gel proved a safe and effective treatment for impotence, according to two U.S. studies presented at the 8th World Meeting on Impotence Research in Amsterdam.
MacroChem's gel, which is rubbed on the penis, was applied to 140 men with erectile dysfunction in two clinical phase 2 trials. In the other trial, of 13 patients in a doctor's office treated with 1 percent of active drug in the gel, 69 percent ''responded with an erection judged adequate for vaginal penetration,'' MacroChem said.
The market for easy-to-use potency drugs is huge, as Pfizer Inc.'s drug Viagra proved by selling $411 million in three months after it was introduced in April. The market for impotence treatment is worth up to $4 billion a year in sales, according to analysts.
''We believe Topiglan may be proven to be an effective drug, with a safety profile acceptable for use in patients with cardiovascular diseases, who may be at risk of serious side effects of agents given by the oral route,'' MacroChem's Chief Executive Officer Alvin Karloff said in a statement.
The gel is applied to the glans, tissue at the end of the penis that hardens or swells. Topiglan allows a common anti-impotence drug to be absorbed into the surface of the skin.
Irwin Goldstein, a researcher and professor at the Boston University School of Medicine, and consultant to MacroChem, who presented the results, said the drug had no side effects except a slight warm irritation on the spot where the gel was rubbed on the penis.
''The topical era will soon be with us,'' said Goldstein. Topical medicines are those that are applied directly to the part of the body they are designed to treat. Topiglan is in the second trial phase of the three that are needed before the company can apply for U.S. regulatory approval to sell the product.
Commonly Used Drug
The drug used in the gel, alprostadil, is also used in Schwarz Pharma AG's injection Edex and Vivus Inc.'s urethra-inserted pellet Muse. What MacroChem adds is its Sepa technology, which increases the porosity of the skin and the access of topically applied drugs.
U.S. pharmaceuticals company NexMed Inc. is also developing a topically applied gel to tread erectile dysfunction, but it will take as much as three more years for the gel to receive marketing approval. MacroChem shares fell 13/16 to 6 yesterday.
quote.bloomberg.com |
