FDA Gives Marketing Approval for Metozolv™ ODT (Orally Disintegrating Tablets)
September 8, 2009 – The FDA has granted marketing approval for the drug metoclopramide (Metozolv) 5mg and 10 mg orally disintegrating tablets. The drug, marketed by Salix Pharmaceuticals, is indicated for the relief of symptoms associated with acute and recurrent diabetic gastroparesis in adults and the treatment of symptomatic documented GERD in adults who do not respond to conventional therapy. Therapy should not exceed 12 weeks in duration.
Metozolv dissolves in the mouth. This could be helpful for patients who need a pro-motility and anti-emetic drug, but are unable to swallow pills or are unable to maintain oral intake due to nausea and vomiting.
In clinical studies, the most frequently reported adverse events (equal or greater than 2% occurrence) were headache, nausea, fatigue, somnolence/drowsiness, and vomiting.
Important Safety Information
Treatment with metoclopramide can cause tardive dyskinesia, a serious movement disorder that is often irreversible. The risk of developing tardive dyskinesia increases with the duration of treatment and the total cumulative dose. Treatment with metoclopramide for longer than 12 weeks should be avoided in all but rare cases where therapeutic benefit is thought to outweigh the risk of developing tardive dyskinesia.
What are Phases?
Treatment trials or studies are in phases:
- Phase 1 tests a new drug or treatment in a small group to evaluate its safety, determine a safe dosage range, and identify side effects;
- Phase 2 expands the study to a larger group of people to see if it is effective and to further evaluate its safety;
- Phase 3 expands the study to an even larger group of people to confirm its effectiveness, monitor side effects, and collect information that will allow the drug or treatment to be used safely.