Orion comments on FDA release on Stalevo
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ORION CORPORATION: Orion comments on FDA release on Stalevo
ORION CORPORATION STOCK EXCHANGE RELEASE 1 April 2010 AT 12.38 EET
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.
Orion Corporation
Timo Lappalainen Olli Huotari
President and CEO SVP, Corporate Functions
Contact person:
President and CEO Timo Lappalainen, phone +358 10 426 3692, gsm +358 50 966 3692
Publisher:
Orion Corporation
Communications
Orionintie 1A, 02200 Espoo
Homepage: www.orion.fi
[HUG#1400245]
Unternehmensinformation / Kurzprofil:
Datum: 01.04.2010 - 11:37 Uhr
Sprache: Deutsch
News-ID 18518
Anzahl Zeichen: 0
contact information:
Town:
Espoo
Kategorie:
Business News
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