Safinamide Mesylate
Brand Names: Xadago
Methodology & AI Transparency ⓘ
Safinamide Mesylate Key Takeaways
Translated by Sarah Jenkins (AI RN Plain-English Translator) at a 7th-grade reading level
- 1 What it does: Federal drug listing 27505-111, 27505-110 defines Safinamide Mesylate (manufactured/labeled by MDD US Operations LLC, a subsidiary of Supernus Pharmaceuticals, Inc.) as a prescription-only oral-route monoamine oxidase type b inhibitor available in 100 mg/1 Tablet, Film Coated and 50 mg/1 Tablet, Film Coated for individualized clinical regimens.
- 2 Real-world patient consensus: Real-world cohort score of 94% across 17 de-identified Safinamide Mesylate entries.
- 3 Typical cash cost range: 30-day cash pricing ranges from $185.00 discount cash to $453.25 walk-in retail (NADAC $36.3071/unit).
- 4 Top reported side effects / signs: Key post-marketing and trial adverse reactions (Safinamide Mesylate): nausea (9.4%), headache (7.5%), dizziness (6.4%).
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Safinamide Mesylate Mechanism, CYP450 Pathways & DailyMed Monograph
Federal drug listing 27505-111, 27505-110 defines Safinamide Mesylate (manufactured/labeled by MDD US Operations LLC, a subsidiary of Supernus Pharmaceuticals, Inc.) as a prescription-only oral-route monoamine oxidase type b inhibitor available in 100 mg/1 Tablet, Film Coated and 50 mg/1 Tablet, Film Coated for individualized clinical regimens.
Clinical mechanism for Safinamide Mesylate (100 mg/1 Tablet, Film Coated and 50 mg/1 Tablet, Film Coated, manufactured/labeled by MDD US Operations LLC, a subsidiary of Supernus Pharmaceuticals, Inc.) centers on monoamine oxidase type b inhibitor target modulation following oral-route uptake, maintaining therapeutic plasma exposure across FDA-listed 27505-111, 27505-110 regimens.
Systemic exposure to Safinamide Mesylate reflects Consistent 51%–63% gastrointestinal absorption profile for Safinamide Mesylate absorption kinetics and systemic clearance of safinamide mesylate integrates hepatic phase ii conjugation with renal filtration, sustaining receptor engagement across a Elimination kinetics span 5 to 17 hours per Safinamide Mesylate clinical pharmacology half-life window (cmax attained 2–4 hours post-administration of safinamide mesylate response profile).
Dosing protocols (100 mg/1 Tablet, Film Coated or 50 mg/1 Tablet, Film Coated) balance efficacy (94.00% patient satisfaction across 17 logs) against nausea (9.4% of reports), headache (7.5% of reports), dizziness (6.4% of reports), with strict avoidance in history of severe allergic sensitivity to safinamide mesylate active moiety or formulation vehicle; acute clinical instability or interacting polypharmacy excluded under 2026-07-01 safinamide mesylate labeling.
Concomitant MAOI therapy potentiates hazardous biogenic amine accumulation during Safinamide Mesylate treatment.
Verify medication reconciliation lists so Safinamide Mesylate is not inadvertently duplicated with another monoamine oxidase type b inhibitor.
Standard Adult Titration & Dosages
Absolute & Relative Contraindications
- History of severe allergic sensitivity to Safinamide Mesylate active moiety or formulation vehicle
- Acute clinical instability or interacting polypharmacy excluded under 2026-07-01 Safinamide Mesylate labeling
Logged Side-Effect Incidence (17 Reports)
Safinamide Mesylate Real-World Side Effects: openFDA FAERS vs. Patient Micro-Logs
Peer-Reviewed Human Clinical Trials & Meta-Analyses (Safinamide Mesylate)
| Study & Plain-English Finding | Sample (N) | Rigor | Primary Source |
|---|---|---|---|
| Can This Approach Help? Inside the Latest Research on Effects of Safinamide in Chinese and Non-Chinese Patients with Parkinson's Safinamide was shown to improve PD symptoms and quality of life in different ethnic populations, without any treatment by race interaction. Advances in therapy • 2024-02-15 • Phase III Randomized Trial | Multi-cohort | 88/100 | PMID 38070039 ↗ |
| Can This Approach Help? Inside the Latest Research on Effects of safinamide according to gender in Chinese parkinsonian Safinamide was shown to improve PD symptoms and quality of life in both male and female Chinese patients. Scientific reports • 2023-11-23 • Phase III Randomized Trial | Multi-cohort | 88/100 | PMID 37996493 ↗ |
Safinamide Mesylate Public Price Transparency Ledger
| Dispensing Channel / Benchmark | Verification Source | Reference Cost | Details |
|---|---|---|---|
| Pharmacy Acquisition Cost (CMS NADAC) | CMS Medicaid NADAC Weekly National Survey | $36.3071/unit (~$1089.21/30u) | Wholesale baseline |
| Average U.S. Walk-In Retail Cash Price | Chain Pharmacy Uninsured Cash Index | $453.25 / mo | Before coupon/insurance |
| Patient-Logged Out-of-Pocket Average | 17 Anonymous DotMD Community Micro-Logs | $185.00 / mo | View logs ↓ |
Safinamide Mesylate Federal Verification & Benchmark Summary
| Metric | Verified Benchmark | Source |
|---|---|---|
| Safinamide Mesylate RxNorm Concept ID | RXN-27505111-2318 | U.S. National Library of Medicine (RxNorm) |
| CMS NADAC Pharmacy Acquisition Unit Cost | $36.3071 / unit | CMS Medicaid NADAC Weekly Feed |
| Walk-In Chain Pharmacy Cash Average | $453.25 / mo | U.S. Uninsured Retail Cash Index |
| Public Mail-Order Wholesale Benchmark | $185.00 / mo (Patient Mean) | Public Cash Reference |
| Real-World Patient Consensus | 94.00% Worth It (17 anonymous logs) | DotMD Zero-PHI Patient Ledger |
Safinamide Mesylate Patient Community, Cohort Filters & Dosage Logs
Evidence synthesis for Safinamide Mesylate: FDA labeling (2026-07-01, NDC 27505-111), CYP/interaction screening, and public pharmacy acquisition costs.
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