NDAORALTABLET, EXTENDED RELEASE
Approved
Feb 2018
Lifecycle
Peak
Competitive Pressure
0/100
Data completeness
4/8 — Partial
OSMOLEX ER (amantadine hydrochloride) by Supernus Pharmaceuticals is clinical pharmacology pharmacodynamics mechanism of action antiviral the mechanism by which amantadine exerts its antiviral activity is not clearly understood. First approved in 2018.
Drug data last refreshed 29m ago · AI intelligence enriched 1w ago
AI summarySynthesized from FDA + DailyMed + ClinicalTrials.gov data
OSMOLEX ER is an extended-release oral formulation of amantadine hydrochloride, a small-molecule antiviral and dopaminergic agent approved in 2018. It treats influenza A virus infections and Parkinson's disease symptoms by inhibiting viral M2 protein function and modulating NMDA receptors and dopamine neurotransmission, respectively. The mechanism in Parkinson's disease remains incompletely understood but involves weak NMDA antagonism and indirect dopaminergic effects.
$0.002BPart D
Peak11.7 years to LOEProduct is at peak lifecycle stage with modest Part D penetration (~$2M in 2023 spending), suggesting stable but niche commercial positioning for a mature therapeutic class.
Mechanism of Action
CLINICAL PHARMACOLOGY Pharmacodynamics Mechanism of Action Antiviral The mechanism by which amantadine exerts its antiviral activity is not clearly understood. It appears to mainly prevent the release of infectious viral nucleic acid into the host cell by interfering with the function of the…
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Data Sources
- Drug label: DailyMed / FDA
- Clinical trials: ClinicalTrials.gov
- Patent data: FDA Orange Book
- Spending data: CMS Medicare
The information on this page is for informational purposes only and should not be used as a substitute for professional medical advice. Drug information is sourced from FDA, DailyMed, and other government databases. Adverse event data from FAERS does not establish causation. Always consult a healthcare professional for medical decisions.