Drugs / Stalevo
Regulatory milestones approvals, filings & regulatory actions · 4 recorded
| Milestone | Jurisdiction | Brand | Indication | Date | Sentence it was read from |
|---|---|---|---|---|---|
| Filed Parkinson disease 2 milestones | |||||
| Filed | US (FDA) | Stalevo | Parkinson disease | — | “Orion applied for an expanded indication for Stalevo® (levodopa, carbidopa and entacapone) in the USA and Europe.” orionpharma.com ↗ “In April, Orion applied for an expanded indication for the Stalevo® drug in the USA and Europe.” orionpharma.com ↗ |
| Filed | EU (EMA) | Stalevo | Parkinson disease | — | “Orion applied for an expanded indication for Stalevo® (levodopa, carbidopa and entacapone) in the USA and Europe.” orionpharma.com ↗ “In April, Orion applied for an expanded indication for the Stalevo® drug in the USA and Europe.” orionpharma.com ↗ |
| Approved Indication not stated 2 milestones | |||||
| Approved | EU (EMA) | Stalevo | — | 2003-10-17 | europa.eu ↗ |
| Filed | Japan (PMDA) | Stalevo | — | — | “Novartis has submitted an application for marketing authorisation for Stalevo in Japan.” orionpharma.com ↗ |
Trials 4
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 11 trial | ||||||
| Phase 1 | NCT01070628 | Dec 2009 → Feb 2010 | Parkinson disease | Orion Corporation, Orion Pharma | Completed | No outcome recorded |
| Phase 42 trials · 1 met primary | ||||||
| Phase 4 | NCT04952194 | Jan 2022 → Dec 2023 | Parkinson disease | Second Affiliated Hospital, School of Medicine, Zhejiang University | Unknown | No outcome recorded |
| Phase 4 | NCT00462007 | Sep 2006 → Aug 2007 | Parkinson disease | Orion Corporation, Orion Pharma | Completed | Met primary |
| Phase not applicable1 trial | ||||||
| — | NCT02452606 | Mar 2015 → May 2017 | Parkinson disease, sleep disorder | Asan Medical Center | Unknown | No outcome recorded |
| Comparator or background therapy1 trial | ||||||
| Phase 2 | NCT01766258 Comparator | May 2011 → Aug 2012 | Parkinson disease | Orion Corporation, Orion Pharma | Completed | No outcome recorded |
News releases announcing trial results or a regulatory action · 16
| Date | Issuer | Release |
|---|---|---|
| 2013-03-21 | Orion Corporation, Orion Pharma | Results Orion Corporation presented promising Phase II data for new Parkinson's disease drug at AAN Annual Meeting orionpharma.com ↗
Both ODM-101/65 mg and ODM-101/105 mg reduced daily OFF-time from baseline more than Stalevo. |
| 2012-10-23 | Orion Corporation, Orion Pharma | Results Orion receives positive Phase II study results of a new levodopa product for Parkinson's disease orionpharma.com ↗
The key results indicate that ODM-101 was more efficacious than the reference product Stalevo® in the treatment of advanced Parkinson's disease patients. |
| 2012-03-26 | Orion Corporation, Orion Pharma | Regulatory Orion comments on ANDA filed by Mylan Pharmaceuticals Inc. for a generic version of Orion's proprietary drug Stalevo® in the United States orionpharma.com ↗ |
| 2010-04-01 | Orion Corporation, Orion Pharma | Regulatory Orion comments on FDA release on Stalevo orionpharma.com ↗
As stated by the FDA in the release, a safety review of Stalevo is ongoing due to the STRIDE-PD study results. |
| 2009-10-21 | Orion Corporation, Orion Pharma | Regulatory Orion withdraws US application for extending the indication of Stalevo® orionpharma.com ↗
Orion Corporation has withdrawn the US application for extending the current US indication of its proprietary drug Stalevo® (levodopa, carbidopa and entacapone) to patients with early Parkinson's disease. |
| 2009-03-06 | Orion Corporation, Orion Pharma | Regulatory Orion withdraws EU application for extending the indication of Stalevo® orionpharma.com ↗
Orion has decided to withdraw its EU application for extending the indication. |
| 2009-02-24 | Orion Corporation, Orion Pharma | Results Orion: Primary objective of STRIDE-PD study was not achieved orionpharma.com ↗
Stalevo does not delay the onset of involuntary movements, dyskinesia. |
| 2008-12-11 | Orion Corporation, Orion Pharma | Regulatory Orion comments on ANDA filed by Wockhardt Limited for a generic version of Orion's proprietary drug Stalevo® (25/200/100; 37.5/200/150 and 50/200/200 mg strengths) in the United States orionpharma.com ↗ |
| 2008-11-03 | Orion Corporation, Orion Pharma | Regulatory Orion comments on ANDA filed by Wockhardt Limited for a generic version of Orion's proprietary drug Stalevo® in the United States orionpharma.com ↗
At this point, the ANDA review process is just beginning and the realisation of generic competition is neither certain nor imminent. |
| 2008-04-15 | Orion Corporation, Orion Pharma | Regulatory Orion seeking broader indication for Stalevo orionpharma.com ↗
Orion Corporation has initiated the regulatory processes for seeking an expanded indication for Stalevo® |
| 2008-01-24 | Orion Corporation, Orion Pharma | Results Positive primary endpoint from FIRST-STEP study with Stalevo in early Parkinson's Disease orionpharma.com ↗
The treatment difference was statistically significant (p<0.05) in favour of Stalevo. |
| 2008-01-02 | Orion Corporation, Orion Pharma | Regulatory Orion comments on new challenge by Sun Pharmaceutical Industries Ltd., India, of Orion's U.S. Patent No. 5,446,194 covering its proprietary drug Stalevo® in the United States orionpharma.com ↗
Sun's amendment to its ANDA involves a Paragraph IV challenge to Orion's U.S. Patent No. 5,446,194. |
| 2007-10-01 | Orion Corporation, Orion Pharma | Regulatory Orion comments on ANDA filing of generic versions of Orion's proprietary drug Stalevo® in the United States orionpharma.com ↗
The application contains so-called Paragraph IV certifications challenging two of six Orion U.S. patents covering Stalevo and listed in the Orange Book, the FDA's official listing of approved drug products. |
| 2003-10-23 | Orion Corporation, Orion Pharma | Regulatory EU approval granted for Stalevo®, Orion's new treatment for Parkinson's disease orionpharma.com ↗ |
| 2003-09-01 | Orion Corporation, Orion Pharma | Results First results of three multicenter open-label clinical trials with StalevoTM show improved symptomatic benefits and enhanced convenience for patients with Parkinson's disease. orionpharma.com ↗
Results from new clinical studies with Stalevo presented today at the 7th Congress of the European Federation of Neurological Societies in Helsinki, Finland confirm clear patient benefits. |
| 2003-06-13 | Orion Corporation, Orion Pharma | Regulatory Stalevo, Orion's new treatment for Parkinson's disease approved by the FDA orionpharma.com ↗
Orion Pharma has received an approval from the US FDA (Food and Drug Administration) for Stalevo, which combines levodopa and carbidopa with entacapone in one tablet for the treatment of Parkinson's disease (PD). |
All press releases naming this drug 28 releases
Evidence & citations 2 cited values
Every value below carries the sentence it was read from. 5 sources stand behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | Stalevo | ClinicalTrials.gov intervention name — accepted as the source's own label NCT01070628 ↗ |
| Route | Oral | “Oral 3-4 daily doses for 6 weeks” NCT00462007 ↗ |