One day after the U.S. Food & Drug Administration (FDA) announced it was investigating the Parkinson’s disease drug <"http://www.yourlawyer.com/practice_areas/defective_drugs">Stalevo for a possible association with prostate cancer, shares of Finnish drug maker Orion fell 10.9 percent in Europe. According to a Reuters report, Orion share were the third most-traded in Helsinki in pre-holiday trade.
The FDA announced the Stalevo review last Wednesday night. According to the agency, data from a long-term clinical trial, known as STRIDE-PD, unexpectedly found that a greater number of patients taking Stalevo had prostate cancer compared to those taking carbidopa and levodopa (sold as Sinemet), a combination medication used to treat Parkinsonâ€™s disease.
The STRIDE-PD trial was a double blind, randomized, parallel group, controlled clinical trial conducted at 77 centers in 14 countries, including 31 sites in the United States, between September 2004 and November 2008. According to the FDA, STRIDE-PD evaluated the time to onset of dyskinesia (difficulty controlling voluntary movement) in patients with Parkinsonâ€™s disease taking Stalevo compared to those taking only carbidopa/levodopa.
Nine out of 245 males had prostate cancer in the Stalevo group compared to two out of 222 males in the carbidopa/levodopa group. The incidence rate of prostate cancer was 14 cases/1,000 patient years for Stalevo and 3.2 cases/1,000 patient years for carbidopa/levodopa.
The FDA notice said that the agency has not concluded that Stalevo increases the risk of developing prostate cancer. The FDA pointed out that prostate cancer is most commonly diagnosed in men who are of the same age as men included in the STRIDE-PD trial. Previous controlled clinical trials of shorter duration evaluating Stalevo in Parkinsonâ€™s disease have not found an increased risk of prostate cancer.