NT201 Toxin
Many of you have written asking about the new ongoing NT201 botulinum toxin being offered under clinical trials by Merz Pharma. This webpage is devoted to directing you to the appropriate site about this new purified botulinum toxin.
Background Information on the FDA Drug Approval Process :
1. Pre-clinical (animal) testing.
2. An investigational new drug application (IND) outlines what the sponsor of a new drug proposes for human testing in clinical trials.
3. Phase 1 studies (typically involve 20 to 80 people).
4. Phase 2 studies (typically involve a few dozen to about 300 people). 5. Phase 3 studies (typically involve several hundred to about 3,000 people).
6. The pre-NDA period, just before a new drug application (NDA) is submitted. A common time for the FDA and drug sponsors to meet.
7. Submission of a new drug application is the formal step asking the FDA to consider a drug for marketing approval.
8. After an NDA is received, the FDA has 60 days to decide whether to file it so it can be reviewed.
9. If the FDA files the NDA, an FDA review team is assigned to evaluate the sponsor’s research on the drug’s safety and effectiveness. 10. The FDA reviews information that goes on a drug’s professional labeling, guidance on how to use the drug.
11. The FDA inspects the facilities where the drug will be manufactured as part of the approval process.
12. FDA reviewers will approve the drug or find it either “approvable” or “not approvable.”
Please visit :
http://www.fda.gov/fdac/features/2002/402_drug.html
http://www.clinicalconnection.com is an excellent site where you can find additional information on new research trials.
About NT201 :
In Europe, NT201 toxin has already received approval under the name of Xeomin® in Germany, Mexico, Argentina, Denmark and Sweden. The median onset of action of XEOMIN® was 7 days after injection; the mean duration of effect was 110 days in clinical trials. Merz is pleased to announce that this toxin is :the first Botulinum neurotoxin type A, free of complexing proteins, meaning that it is highly pure and free of other interfering substances. Highlights of this Toxin include :
- Low antibody formation potential
- Stable without refrigeration
- Well known safety and efficacy.
About the NT201 Clinical Trials for Cervical Dystonia in the U.S. are no longer enrolling patients for the trial. However, for Blepharospasm, the Web site DystoniaStudies and the associated phone number are no longer active. Anyone searching for information can go to www.clinicaltrials.gov and search for the protocol number - 60201-0433 regarding this specific trial.
Source : Merz Pharma 2007