Trial Profile
Two-Period, Two-Treatment, Randomized Crossover Study of the Pharmacokinetics of Nalmefene by Intranasal and Intramuscular Administration in Healthy Volunteers
Status:
Completed
Phase of Trial:
Phase I
Latest Information Update: 26 May 2023
Price :
$35
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At a glance
- Drugs Nalmefene (Primary) ; Nalmefene
- Indications Opioid-related disorders
- Focus Pharmacokinetics; Registrational
- Sponsors Opiant Pharmaceuticals
- 22 May 2023 According to a Food and Drug Administration media release, the U.S. Food and Drug Administration approved Opvee nasal spray. The approval of Opvee was supported by safety and pharmacokinetic studies, as well as a study in people who use opioids recreationally to assess how quickly the drug works.
- 19 Jan 2023 According to an Opiant Pharmaceuticals media release, the U.S. Food and Drug Administration (FDA) has accepted for review the New Drug Application (NDA) for OPNT003. The NDA was granted a Priority Review designation and has been given a Prescription Drug User Fee Act (PDUFA) action date of May 22, 2023, accelerating the review time from ten months to six months from the date of filing.
- 22 Nov 2022 According to an Opiant Pharmaceuticals media release, company announced it has completed submission of its rolling New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) seeking approval for OPNT003, nasal nalmefene, for the treatment of opioid overdose, NDA submission is supported by results from a PK study (NCT04759768), a second PK study (NCT05219669), and a PD study (NCT04828005). The FDA decision on NDA filing acceptance is expected in February 2023.