NDANASALSPRAY, METERED
Approved
Mar 2023
Lifecycle
Post-LOE
Competitive Pressure
35/100
Data completeness
3/8 — 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. Approved for opioid overdose, fentanyl overdose. First approved in 2023.
Drug data last refreshed 22h ago · AI intelligence enriched 2w ago
AI summarySynthesized from FDA + DailyMed + ClinicalTrials.gov data
REXTOVY is a metered nasal spray formulation of naloxone hydrochloride approved in March 2023 for rapid reversal of opioid overdose, including fentanyl. It works as a pure opioid antagonist by competing for µ, κ, and σ receptor sites in the CNS, with fastest action at the µ receptor. The nasal route enables rapid onset (within 2 minutes IV equivalent) and is designed for emergency use in opioid poisoning scenarios.
Post-LOEPost-LOE
REXTOVY entered a crowded, post-LOE market in 2023 with moderate competitive pressure (35/100), suggesting defensive positioning by R-Pharm and smaller team expansion opportunities.
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.