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Potential new treatment for people with manic depression

Drug company AstraZeneca said it has submitted an application to the U.S. Food and Drug Administration for approval of quetiapine (Seroquel) as a treatment for acute mania associated with bipolar disorder, or manic-depressive illness. The application follows the completion of a clinical trial programme in bipolar disorder undertaken by the company which reportedly found quetiapine effective as a treatment of acute mania on two levels: as monotherapy (i.e to be prescribed on its own) and as adjunctive therapy with standard mood stabilising medication. These clinical trials have delivered strong and positive results in both the monotherapy and adjunctive therapy studies, which confirm quetiapine to be an ideal first line therapy for the treatment of acute mania associated with bipolar disorder, the company said.

White House to ask for pediatric drug trials

The Bush Administration said it will ask Congress for legislation requiring drug companies to conduct pediatric clinical trials on new medicines. Clearer legislative authority is needed, instead of pursuing appeals in the courts, the administration believes. “The fastest and most decisive route for establishing clear authority in this area is to work with Congress for new legislation,” Secretary Tommy Thompson said. “Children are a special population that need to have access to drugs that can benefit them, and these drugs need to be properly tested for pediatric use, not prescribed and sold without testing. Congress alone can speak clearly on the authority that FDA needs and the provisions that may be appropriate for drug manufacturers when they are required to carry out these tests.”

Feds approve nicotine lozenges

The U.S. Food and Drug Administration has approved a nicotine throat lozenge meant to help smokers kick the habit. The sweets will be sold in stores alongside similar gums and patches. Maker GlaxoSmithKilne says the over-the-counter lozenges will come in two strengths to provide smokers with a source of nicotine that helps them avoid cigarette cravings and withdrawal symptoms while they try to quit.

Test could reduce need for biopsies in prostate disease

Men who test positive for elevated prostate specific antigen (PSA) levels sometimes freak out because they think it means they have cancer. To find out, a surgeon will often perform a biopsy. But researchers from the National Cancer Institute and the Food and Drug Administration report that a new test using a single drop of blood could help distinguish between prostate cancer and benign conditions. The trick is identifying patterns of proteins found in patients’ blood serum.