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Anne Chalfant New pharmaceuticals designed specifically for children could soon allow healthcare professionals to do things that were once unimaginable—close wounds without sutures, mask the bad taste of some medications, and eliminate ear infections. At least 187 pediatric pharmaceuticals—an unprecedented number—are in development, according to a recent survey by Pharmaceutical Research and Manufacturers of America (PhRMA). That’s a cornucopia of vaccines and treatments for children that could spill onto the market in the next few years. Since January, the Food and Drug Administration (FDA) has approved at least 20 new pediatric pharmaceuticals, including a protease inhibitor to treat AIDS, medicines for cystic fibrosis and epilepsy, and a single-dose antibiotic for ear infections.
In addition, Studies meeting FDA standards could earn companies an additional six months of exclusive rights to market the drug for pediatric patients, according to Khyati Roberts, science policy analyst at the Center for Drug Evaluation and Research of the FDA in Rockville, Md. A significant increase The fact that 187 medicines and vaccines are in development specifically for pediatric use "represents a significant increase in industry investment in drugs and therapeutics for children," said pediatrician John Siegfried, MD, PhRMA’s senior medical officer. He cites several reasons for the increase, including technologies that allow far less invasive testing of children—such as blood sample tests that only require a small amount of blood. "Ten to 15 years ago you might have had to draw four or five blood samples; now there are micro-technologies that allow you to do studies on small quantities of blood," he said. Some of the most promising treatments could hit the market soon. A technology that masks bad tastes has been already been patented by Ascent Pediatrics, which has applied it to its liquid asthma treatment, Orapred. If approved by the FDA, Orapred will be an important drug for asthmatic infants and young children, Siegfried said, because there has not been a pediatric formulation for prednisolone. "That’s a tremendous help for kids." Looking forward And in the next few years, a vaccine may be approved that prevents ear infections—a torment for young children that results in 30 million pediatric visits a year, according to Kaiser Permanente. Kaiser has completed Phase III of clinical trials for a vaccine that combats the pneumococcus bacteria, which is responsible for otitis media, as well as pneumonia and bacterial meningitis. The trials involved 38,000 children in Northern California. The vaccine was developed by Wyeth-Ayerst Laboratories of Radnor, Pa. Wyeth Lederle Vaccines plans to submit a product license application for the vaccine to the FDA by the first quarter of 1999. "We are entering an era in which effective protection against invasive pneumococcal disease, and, potentially, otitis media, should become a reality for children throughout the world," said Steven Black, MD, co-director of the Kaiser Permanente Vaccine Study Center in Oakland, Calif. "We are especially hopeful the vaccine will prevent a significant number of ear infections of children of all ages." One pharmaceutical in development may bring hope for some of medicine’s tiniest patients. Cytel Corp. is testing a drug, Cylexin, that may improve the prognosis for infants undergoing hypothermic cardiopulmonary bypass during surgical repair of congenital heart defects. During this procedure, infants sometimes suffer reperfusion injury, a situation in which white blood cells stick to blood vessel walls and migrate through them, releasing damaging enzymes into tissue, said Linda Heiner, spokesperson for the San Diego-based company. There are no existing drugs to prevent reperfusion injury in this patient population, according to Cytel. Cylexin is in Phase I/II and has "Orphan Drug Status" from the FDA. (Orphan drugs are used to treat diseases affecting fewer than 200,000 people in the United States, and manufacturers can be granted special privileges and marketing incentives to produce such products.) Of course, not all
the medicines and vaccines in development will meet FDA standards and
make it to the marketplace. But the list is still wide-ranging, including
44 drugs that target cancer, 14 that are being tested for cystic fibrosis,
13 that are being tested for asthma, |
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