Magazine article Drug Topics

Newsbriefs

Magazine article Drug Topics

Newsbriefs

Article excerpt

Nevirapine affects triglyceride levels: Data presented at the Conference on Retroviruses and Opportunistic Infections in Seattle found that HIVpositive individuals who transitioned from protease inhibitor-based therapy to nevirapine (Viramune, Roxane Laboratories) had a significant reduction in their mean serum triglycerides compared with patients who switched to an abacavir (Ziagen, GlaxoSmithKline)- or an efavirenz (Sustiva, BristolMyers Squibb)-based regimen. This investigation is the first to evaluate metabolic and body composition changes comparing three available PIsparing regimens. Rashes and hepatic events are the most significant side effects associated with nevirapine treatment. The adult dosage of nevirapine is 200 mg/d for the first 14 days, after which the dosage can be titrated to 200 mg b.i.d.

* New nonpeptidic protease inhibitor. Researchers at the retrovirus conference in Seattle also reported that tipranavir-based therapy achieved and maintained viral suppression in HIV-positive patients infected with multiple-drug-resistant virus. Tipranavir (Boehringer Ingelheim) is the first nonpeptidic protease inhibitor under development to treat HIV-1 infection. The researchers claim the drug's nonpeptidic chemical structure is unique compared with that of the currently available protease inhibitors. "These data should guide the development of tipranavir as effective therapy for protease-inhibitor resistant HIV-1 infection," said Martin Markowitz, M.D., investigator at the Aaron Diamond AIDS Research Center in New York.

* FDA to review alcohol dependence drug: The NDA for acamprosate (Campral), a drug to treat alcohol dependence, has recently been granted a priority review by the FDA. Experts believe this drug, now in development in the United States, could represent the first significant development in the treatment of alcohol dependence in recent years. Acamprosate is currently available by prescription in 24 countries. According to a review article published in JAMA, acamprosate therapy resulted in a 20% increase in "nondrinking days" among patients in nine European clinical trials. Observed side effects were tolerable, transient, and minimal. Diarrhea was the most common adverse event. The drug will be marketed in the United States by Forest Laboratories, licensee of Lipha S.A., a subsidiary of Merck KgaA.

* New orphan drug: The FDA has granted orphan drug status to NeoPharm's mesothelin monoclonal antibody toxin, SSl-PE38, for the treatment of mesothelioma and ovarian cancer. …

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