Advances in molecular biology and genomic medicine are increasing the odds that compounds dreamed up by scientists make it from the lab to the pharmacy. Here are some of the latest candidates, either just approved by the Food and Drug Administration (FDA) or under review. •DIABETES If you’re a diabetic and the daily injections of insulin are torture, then get ready for some relief. Pfizer received FDA approval in January to market the first inhaled insulin, Exubera, which should become available around midyear. The powdered insulin, taken just before meals, is released into the mouth and lungs through an inhaler similar to the ones that asthma patients use. In studies of more than 2,500 adults with either Type 1 or Type 2 diabetes, the needle-free insulin was as effective as short-acting insulin shots in controlling blood-sugar levels. •OBESITY
When scientists at Sanofi-Aventis took on the challenge of developing a weight-loss drug, they chose an unusual approach. Instead of studying ways to curb the body’s natural desire to eat, they decided to home in on the very biological circuits that activate hunger. Even more unorthodox was the craving phenomenon they decided to analyze: the marijuana munchies. If marijuana can trigger the appetite, then perhaps that system could be coaxed into switching off.
Rimonabant, the weight-loss compound they developed, is the first drug that manipulates the endocannabinoid system, a network of cells in the brain, the liver and fat tissue that regulates hunger by linking appetite to the body’s reward and satisfaction system. Rimonabant reduces food cravings by deactivating the cannabinoid receptors. The drug, to be marketed as Acomplia, is being reviewed by the FDA and will be targeted at those who not only carry excess weight but also harbor unhealthy signs of metabolic disorders such as diabetes and hypertension. In half a dozen clinical trials, the compound helped 6,000 patients lose up to 10% of their body weight over a year and maintain that loss for another year. And because rimonabant works in liver and fat cells as well, it also improved the patients’ cholesterol profiles, boosting “good” HDL levels and lowering amounts of dangerous triglyceride fats in the blood. •CERVICAL CANCER Cancer is always tricky to treat, but if the malignancy is caused by a virus, then the disease becomes a little more manageable, thanks to vaccine technology. Both Merck and GlaxoSmithKline have created cervical-cancer vaccines, but Merck’s Gardasil was first to the FDA, which is expected to make its decision by June.
Gardasil protects against four types of human papillomavirus, which account for the vast majority of the 500,000 cervical-cancer cases and the 32 million new cases of genital warts around the world each year. Last fall Merck released encouraging results from its clinical trial in which 755 healthy sexually active women were injected with the protective shots three times over six months and none developed precancerous growths in the cervix after four years.
As encouraging as those results were, however, Gardasil may face its toughest challenge after it reaches the market. Public-health officials are considering adding the inoculation to the roster of shots that children receive before they become sexually active, since that’s when the vaccine is most effective at preventing infection. Religious and parent groups, however, are concerned that Gardasil may encourage sex by promoting the idea that it’s risk-free •SHINGLES In Italy it’s called St. Anthony’s fire, a vivid description for the red, blistery and often painful rash that 1 million adults in the U.S. each year come to know as shingles. Merck is awaiting FDA approval for its shingles shot, Zostavax, which is designed to prevent shingles in those who are most vulnerable to the disease–adults over age 60. Shingles occurs when the chicken-pox virus from a childhood infection is reactivated–usually by the decline in immunity that comes with age–and travels from the nerve cells where it has remained dormant, all the way to the skin, where it blossoms into the condition’s hallmark lesions. Zostavax contains a crippled form of the chicken pox’s varicella zoster virus, and jump-starts the body’s immune system, boosting the defense cells specifically designed to attack varicella. In trials with nearly 40,000 subjects, the vaccine reduced rash and pain from shingles by more than 60% in elderly adults. •AIDS Doctors are close to adding one more powerful ingredient to their antiviral recipe against AIDS. Researchers at Pfizer have developed the first in a new class of compounds that would prevent HIV from entering and infecting a healthy cell. So far, the medications that have saved millions of AIDS patients around the world have thwarted HIV at the end of its reproductive cycle; Pfizer’s compound, a once-a-day pill called Miraviroc, targets the beginning of the disease process. Now in the last stage of being tested in patients, the compound, in combination with other anti-HIV drugs, could become a significant roadblock in preventing HIV infections from mushrooming into full-blown cases of AIDS. •INSOMNIA Getting a good night’s sleep is an ordeal for 70 million Americans. Medications like Ambien can help, but because they target neurons in the brain that control both wakefulness and muscle relaxation, sometimes they work too well, leaving you groggy the next morning. Neurocrine’s Indiplon avoids that aftereffect by selectively targeting just the nerve receptors in the brain that regulate sleep. Patients using Indiplon were able to fall asleep within 15 minutes and sleep an average of an hour longer than those taking other sleep aids. The company, which expects to hear by May whether the FDA will approve its drug, plans to market Indiplon in two forms: a short-acting version and an extended-release form for those with more serious insomnia.
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