Orion comments on FDA release on Stalevo
Referring to the release published by the US Food and Drug Administration (FDA) on 31 March 2010 concerning the safety review of Orion's drug Stalevo (levodopa/carbidopa/entacapone) , Orion provides the following comment:
As stated by the FDA in the release, a safety review of Stalevo is ongoing due to the STRIDE-PD study results. The release highlights that, at this time, no new conclusions or recommendations about the use of this drug have been made. According to FDA, patients should not stop taking their medication unless directed to do so by their healthcare professional.
The FDA also states that its communication is in keeping with FDA's commitment to inform the public about its ongoing safety review of drugs and that the agency will update the public as soon as the review is complete.
Orion has informed about the results of the STRIDE-PD study in a stock exchange release on 24 February 2009. In the said release, the safety and tolerability findings of the study were provided as follows:
Safety and tolerability
The known gastrointestinal disorders of nausea and diarrhea were more frequently reported with Stalevo. Preliminary results indicate that, although the frequency of ischemic heart disease events in STRIDE-PD was similar compared with previous entacapone studies as well as the incidence noted in a similarly-aged general population, less events of myocardial infarction were observed in the carbidopa/levodopa group. Overall, the occurrence of neoplasm was similar in both treatment groups, but there were less cases of prostate cancer and more cases of skin cancer in the carbidopa/levodopa group. These imbalances are being investigated, and discussion with the regulatory authorities is ongoing.
At this stage, Orion has no further details to add to the already published information concerning Stalevo and the results of the STRIDE-PD study. Orion has no information of when the safety evaluation will be completed.
Timo Lappalainen Olli Huotari
President and CEO SVP, Corporate Functions
President and CEO Timo Lappalainen, phone +358 10 426 3692, gsm +358 50 966 3692
Orionintie 1A, 02200 Espoo