NDANASALSPRAY, METERED
Approved
Mar 2023
Lifecycle
Post-LOE
Competitive Pressure
35/100
Data completeness
2/8 — Basic
REXTOVY (naloxone hydrochloride) by R-Pharm US is clinical pharmacology complete or partial reversal of opioid depression naloxone hydrochloride prevents or reverses the effects of opioids including respiratory depression, sedation, and hypotension. First approved in 2023.
Drug data last refreshed 2d ago · AI intelligence enriched 1w ago
AI summarySynthesized from FDA + DailyMed + ClinicalTrials.gov data
REXTOVY is a metered nasal spray formulation of naloxone hydrochloride, a pure opioid antagonist that rapidly reverses opioid depression including respiratory depression, sedation, and hypotension. It works by competing for μ, κ, and σ opioid receptor sites in the CNS with greatest affinity for the μ receptor. REXTOVY is indicated for the emergency treatment of known or suspected opioid overdose.
Post-LOEPost-LOE
Product is post-LOE with a 2026 patent expiration, indicating a contracting team focused on defending market share against generic/competing formulations rather than growth initiatives.
Mechanism of Action
CLINICAL PHARMACOLOGY Complete or Partial Reversal of Opioid Depression Naloxone hydrochloride prevents or reverses the effects of opioids including respiratory depression, sedation, and hypotension. Also, naloxone hydrochloride can reverse the psychotomimetic and dysphoric effects of…
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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.