Trial Profile
A Phase 1, Open Label, Randomized Study to Investigate the Pharmacokinetics and Safety of Multiple Doses of Intranasal Naloxone in Healthy Adult Participants
Status:
Completed
Phase of Trial:
Phase I
Latest Information Update: 31 Mar 2023
Price :
$35
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At a glance
- Drugs Naloxone (Primary)
- Indications Opioid-related disorders
- Focus Adverse reactions; Pharmacokinetics
- Sponsors Emergent BioSolutions
- 29 Mar 2023 According to a Emergent BioSolutions media release, the U.S. Food and Drug Administration (FDA) has approved NARCAN Naloxone HCl Nasal Spray 4 mg as an over-the-counter (OTC) emergency treatment of opioid overdose, supported by Human Factors study data, an updated Drug Facts label, pharmacovigilance data collected from various public sources, and seven years of post-marketing safety data.
- 15 Feb 2023 According to a Emergent BioSolutions media release, the U.S. Food and Drug Administration (FDA) Nonprescription Drugs Advisory Committee and the Anesthetic and Analgesic Drug Products Advisory Committee have unanimously voted in favor (a total of 19 votes) that the benefit-risk profile of NARCAN Nasal Spray is supportive of its use as a nonprescription opioid overdose reversal agent.
- 15 Feb 2023 According to a Emergent BioSolutions media release, the company was a first to submit a supplemental New Drug Application for OTC and received Priority Review by the FDA. The Prescription Drug User Fee Act goal date is March 29, 2023.