Trial reportPharmaceutical research2022
A Novel Faster-Acting, Dry Powder-Based, Naloxone Intranasal Formulation for Opioid Overdose.
Trial report in Pharmaceutical research, 2022. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT04713709 (A Single-Dose, Bioequivalence Study of FMXIN001 4 mg Microspheres Powder and Narcan® 4 mg/0.1 mL Nasal Spray Under Fasting Conditions), which is not on this map. Cited by 6 papers.
What it found
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The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.
The trial behind it
Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.
A Single-Dose, Bioequivalence Study of FMXIN001 4 mg Microspheres Powder and Narcan® 4 mg/0.1 mL Nasal Spray Under Fasting Conditions
Who cites it
6 citing papers in PubMed, 12 citations in OpenAlex.
- A Phase 1, Open-Label, Randomized Study to Investigate the Pharmacokinetics and Safety of Multiple Doses of Intranasal Naloxone in Healthy Participants.Clinical and translational science · 2026Trial
- Raman Imaging-based Analysis of Drug Powder Dissolution on Calu-3 Cell Monolayers as a Mechanistic Predictor of Nasal Absorption.Pharmaceutical research · 2026Article
- First-in-class intranasal epinephrine spray for anaphylaxis: Dose finding clinical study.The journal of allergy and clinical immunology. Global · 2025Article
- Characterization of Spray-Dried Powders Using a Coated Alberta Idealized Nasal Inlet.Journal of aerosol medicine and pulmonary drug delivery · 2025Article
- Clinical Pharmacokinetics and Pharmacodynamics of Naloxone.Clinical pharmacokinetics · 2024Review
- Instillation of a Dry Powder in Nasal Casts: Parameters Influencing the Olfactory Deposition With Uni- and Bi-Directional Devices.Frontiers in medical technology · 2022Article
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
7 authors at 3 institutions in 3 countries.
Funding
No grant is acknowledged in the PubMed record.
Abstract
objectiveTo examine the pharmacokinetics and safety of FMXIN001, a new intranasal powder-based naloxone formulation, in comparison to Narcan® nasal liquid spray.
methodsFMXIN001, was developed by blending drug microspheres with larger lactose monohydrate particles, that serve as diluent and carrier, as well as a disaggregating agent. Scanning electron microscopy and X-ray were used to characterize the formulation and in vitro deposition was investigated using a nasal cast. We compared the pharmacokinetics and safety of FMXIN001 versus Narcan® in two clinical trials: a pilot study with 14 healthy adults and a pivotal trial in 42 healthy adults (NCT04713709). The studies were open-label, single-dose, randomized, two-period, two-treatment, two-sequence crossover studies to assess the pharmacokinetics and safety of FMXIN001 versus Narcan® nasal spray.
resultsFMXIN001 comprises naloxone microspheres (5-30 μM) and lactose particles (40-240 μM). Upon in vitro testing, naloxone deposits mainly to the middle turbinates region and the upper part of the nasal cavity of a nasal cast. In human subjects, FMXIN001 produced significantly higher exposure at the initial time points of 4, 10, and 30 min, post-administration, compared to Narcan®. Both treatments were safe and well tolerated. FMXIN001, powder-based spray, results in similar overall exposure to Narcan®, but with more rapid absorption in the first 30 min.
conclusionsFMXIN001 is expected to have a shorter onset of action for a more effective therapeutic intervention to manage opioid overdose. Rapid administration of naloxone in cases of opioid overdose is imperative, given the alarming increase in mortality rates.
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Registered trials
Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.