FDA reviewing safety of Stalevo

Orion Corp. (HSE:ORNAV; HSE:ORNBV) fell EUR 1.56 (10%) to EUR 14.70 on Thursday after FDA said on Wednesday it would review the safety of Stalevo levodopa/carbidopa/entacapone. The agency cited data from the four-year Phase III STRIDE-PD trial that showed an increased incidence of prostate cancer in patients receiving the drug compared to control. Specifically, nine (3.7%) out of 245 males in the Stalevo group had prostate cancer vs. two (0.9%) out of 222 males in the carbidopa/levodopa group. FDA said previous Stalevo trials lasting less than a year did not show an increased risk of prostate cancer. ...