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 10h ago · AI intelligence enriched 6d ago
AI summarySynthesized from FDA + DailyMed + ClinicalTrials.gov data
REXTOVY is a metered nasal spray formulation of naloxone hydrochloride, a pure opioid antagonist approved in March 2023. It rapidly reverses opioid-induced respiratory depression, sedation, and hypotension by competitively blocking µ, κ, and σ opioid receptors in the CNS. The nasal route provides faster onset than some alternative delivery methods and addresses the critical public health need for accessible opioid overdose reversal.
Post-LOEPost-LOE
Post-LOE positioning suggests mature market focus; commercial team likely prioritizing generic transition strategy and niche market defense rather than growth expansion.
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.