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NEW YORK (Reuters) - Eli Lilly and Co on Tuesday said U.S. regulators approved once-daily use of two low-dose forms of its Cialis anti-impotence drug, offering greater convenience for men expecting frequent sexual activity.

The Indianapolis drugmaker said the once-daily formulations, in dosages of 2.5 milligrams and 5 milligrams, will allow men to attempt sexual activity any time between doses.

“In clinical trials, when taken without restrictions on the timing of sexual activity, Cialis for once daily use improved erectile function over the course of therapy,” Lilly said in a release.

The low-dose daily formulations, already approved in parts of Europe, “may be most appropriate for men with erectile dysfunction who anticipate more frequent sexual activity (e.g. twice weekly),” Lilly said.

In a move that could help give Indianapolis drugmaker Eli Lilly and Co. an edge over its rivals in the growing market for erectile dysfunction, the U.S. Food and Drug Administration has approved Cialis for daily use.

The once-a-day version will be marketed for men who anticipate having sex two or more times a week, without confining it to a limited time frame. The current dosage of Cialis works for about 36 hours. Viagra and the other major erectile-dysfunction drug, Levitra, work for about four hours.
When Cialis is taken daily, men can attempt sexual activity at any time between doses. The low-dose daily version of the drug is already available in parts of Europe, Lilly said. Neither Viagra nor Levitra, a pair of competitors, is sold in once-daily doses.

Regulators in India have rejected a patent claim by Indianapolis-based Eli Lilly and Co. for it’s Cialis erectile dysfunction drug.

The drug’s basic components were synthesized in 1970 by Indian scientists at a government body that researches pharmaceuticals, the Central Drug Research Institute, an Indian drug-maker contended.

Moreover, Ajanta Pharma argued, the Indian scientists obtained a U.S. patent on the development five years later.

If Lilly’s appeal of the decision fails, Cialis will compete with less-expensive forms of the drug in one of the world’s largest markets.

Lilly’s predicament was the subject of an article in the Business Standard, an Indian business newspaper.

The remaining up-and-running part of Bothell’s former Icos Corp. — a facility that manufactures therapeutic proteins for clinical trials — will undergo a significant expansion under its new owner.

In January, Eli Lilly & Co. of Indianapolis bought Icos, best known for its Cialis erectile dysfunction drug, and closed the company’s Washington operations, except for the manufacturing facility, which it put up for sale.

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Late Monday, a Danish company, CMC Biopharmaceuticals, said it had bought the facility and would retain the 127 workers. It was bittersweet news, since Icos once employed almost 700.

Nov. 12 (Bloomberg) — Eli Lilly & Co.’s impotence drug Cialis helped men with spinal cord injuries achieve erections that allowed them to have sexual intercourse, researchers said.

Cialis helped improve penetration and increased the frequency of ejaculation, the study found. Spinal cord injury occurs most often in young men, and restoring sexual activity can improve their quality of life, according to research published in today’s journal Archives of Neurology.

More than 200,000 Americans have spinal cord injuries. Each year 10,000 people in the U.S. are disabled from automobile, sports and work accidents, falls or wounds during military service, according to the Paralyzed Veterans of America Web site. Only one-fourth of men with such injuries have erections adequate for intercourse, because in the other three-fourths of the men the spinal cord nerves that send messages from the brain to the penis are damaged, researchers said.

NEW YORK (Reuters Health) - A long-acting drug for erectile dysfunction is safe and effective for men with spinal cord injuries who have difficulty achieving erections, a new study shows.

A total of 186 men were randomly assigned to receive treatment with Cialis or placebo for 12 weeks. The study was completed by 129 in the treatment group and by 34 in the placebo group. The subjects, who were an average of 38 years old, had experienced erectile dysfunction for six months or longer. They were instructed to take the drug when they planned to have sex.

Doctors who prescribe Viagra, Cialis and Levitra will need to read up on a new information sheet released by the Food & Drug Administration (FDA) regarding sudden hearing loss associated with the erectile dysfunction drugs. Last month, the FDA warned that Viagra, Levitra, and Cialis have been connected with more than two dozen instances of sudden hearing loss. Those reports prompted the FDA to announce that the labels on these erectile dysfunction drugs would bear new warnings about this potential side effect.

LOS ANGELES (AP) — Many of the pills marketed as safe herbal alternatives to Viagra and other prescription sex medications pose a hidden danger: For men on common heart and blood-pressure drugs, popping one could lead to a stroke, or even death.

“All-natural” products with names like Stamina-RX and Vigor-25 promise an apothecary’s delight of rare Asian ingredients, but many work because they contain unregulated versions of the very pharmaceuticals they are supposed to replace.

That dirty secret represents a special danger for the millions of men who take nitrates — drugs prescribed to lower blood pressure and regulate heart disease. When mixed, nitrates and impotency pharmaceuticals can slow blood flow catastrophically, leading to a heart attack or stroke.