Orion comments on today's FDA release on safety review of Stalevo®
FDA release deals with cardiovascular events reported in STRIDE-PD study and relates to the ongoing US safety review of Stalevo
A release relating to the ongoing safety evaluation of Orion's Parkinson's disease medicine Stalevo (levodopa, carbidopa, entacapone) has been published today, 20 August 2010, by the US FDA (Food and Drug Administration) on its website. The FDA release deals with the cardiovascular events reported in the results of the STRIDE-PD, a Phase III clinical study conducted with Stalevo. Referring to the release, Orion comments as follows:
Orion initially 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: "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."
Since the completion of the STRIDE-PD study in 2009, Orion submitted its own analysis of all previous entacapone studies to both the US FDA and the European Medicines Agency EMA. The EMA completed its safety review in March 2010 with modifications to the SPC (Summary of Product Characteristics) of Stalevo. The FDA review of the data is still ongoing, and Orion continues to collaborate with the agency for all possible questions.
In accordance with its commitment to transparency, the FDA publishes interim announcements and final conclusions of ongoing and completed safety reviews of drugs available on the US market on its internet website. In its release of 20 August, the FDA points out that healthcare professionals should regularly evaluate the cardiovascular status of patients who are taking Stalevo, especially if they have a history of cardiovascular disease. Patients should not stop taking their medication unless told to do so by their healthcare professional.
The FDA also states that the agency will update the public as soon as the review is complete. At this stage, Orion is not informed of when the evaluation is scheduled to be completed.
Timo Lappalainen Olli Huotari
President and CEO SVP, Corporate Functions
Until 22 August 2010: President and CEO Timo Lappalainen, phone +358 10 426 3692,
gsm +358 50 966 3692
As of 23 August 2010: Reijo Salonen, Senior Vice President, R&D, phone 358 10 426 3647,
gsm +358 50 966 3647
Orionintie 1A, 02200 Espoo