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Biotech / Medical : PFE (Pfizer) How high will it go? -- Ignore unavailable to you. Want to Upgrade?

To: BigKNY3 who wrote (6707)	1/15/1999 10:22:00 AM
From: Hunter Vann	Read Replies (1) \| Respond to of 9523

Interesting news from my home state.... UK professors develop nasal spray for Viagra but cannot market it By Krista Larson HERALD-LEADER STAFF WRITER A nasal drug delivery system developed by two University of Kentucky College of Pharmacy faculty members may make Viagra more convenient and safer to use. Lewis Dittert and Anwar Hussain, both professors, have created the first soluble version of the Viagra's active ingredient, sildenafil. This allows Viagra to be administered nasally so it can be absorbed directly into the bloodstream. Patients could get results in five to 15 minutes with a lower dose, Dittert said. But don't get too excited: The spray is not on the market. Dittert and Hussain cannot make, sell or use Viagra without the permission of Pfizer Inc. There is no commercial source, other than Pfizer, for the active ingredients in Viagra. ''We're not trying to steal their compound,'' Dittert said. ''We want to help them make a better product.'' Neither aspires to market their product; they would like to license it out to someone else. Viagra, which was approved last March to treat impotency in men, can take up to an hour or more to take effect. ''We feel because of the nature of Viagra's use that people don't want to wait an hour for results,'' Dittert said. The active ingredient in the Viagra tablet is poorly soluble in water and becomes even less soluble when it reaches the small intestine where it is absorbed by the blood, Dittert said. With food in the stomach, the waiting time for the drug to take effect can be even longer. That can create a potentially dangerous overdose situation if patients take more than the recommended dosage in an attempt to get results quickly. ''Men may become impatient and do foolish things because of the demands of the situation,'' Dittert said. It can be particularly dangerous because many men who take Viagra have pre-existing heart problems, Dittert said. Cardiovascular problems or drugs taken to treat them often contribute to impotency. Those problems can be complicated by an overdosage of Viagra, he said. Dittert and Hussain developed the nasal spray at their company, New Millennium Pharmaceutical Research Inc., at Advanced Science and Technology Commercialization Center on the UK campus. Hussain's experience with nasal drug delivery led him to believe Viagra would be an excellent candidate for nasal administration. Hussain and Dittert have studied nasal drug delivery systems for more than 15 and 10 years, respectively. Hussain's research has also led to the award of a patent to Hussain and the University of Kentucky Research Foundation on intranasal administration of butorphanol and numerous other major analgesic drugs. Within a month of Viagra hitting the markets, Hussain mentioned the idea to Dittert. ''From a structural standpoint, it should work,'' Hussain said. ''From therapeutic needs, it is important for the compounds to get into the blood very quickly.'' The two filed for a provisional patent last June. After conducting some initial research at the University of Iowa, they decided to apply for a full patent. Dittert and Hussain would like to collaborate with Pfizer Inc., the pharmaceutical company that manufactures Viagra. Pfizer Inc. has not expressed an interest to Dittert or Hussain. ''We have a great drug on the market, when used appropriately,'' said Mariann Caprino, a spokeswoman for Pfizer. ''It's a tremendous breakthrough just to have it available in pill form.'' Viagra absorbed nasally would take three to four years to become available, Dittert said. Their research will need to be reviewed and approved by the Food and Drug Administration. Additional animal work and a well-controlled clinical study with humans will also be required, Dittert said. Dittert remains optimistic about the results achieved in tests on rats. ''We've never seen a compound absorbed in rats and not in humans,'' he said.