Either you have JavaScript disabled or your browser does not support Javascript . To work properly, this page requires JavaScript to be enabled.
How to enable JavaScript in your browser?

Two-Period, Two-Treatment, Randomized Crossover Study of the Pharmacokinetics of Nalmefene by Intranasal and Intramuscular Administration in Healthy Volunteers

Next Previous
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 *
  • Adis is an information provider.
  • Final gross price and currency may vary according to local VAT and billing address.
  • Your purchase entitles you to full access to the information contained in our trial profile at the time of purchase.
  • A link to download a PDF version of the trial profile will be included in your email receipt.

At a glance

  • Drugs Nalmefene (Primary) ; Nalmefene
  • Indications Opioid-related disorders
  • Focus Pharmacokinetics; Registrational
  • Sponsors Opiant Pharmaceuticals

    • Most Recent Events

    • 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.
Subscriber content

You need to be a logged in subscriber to view this content.

If your organization has a subscription then there are several options available to help you access AdisInsight, even while working remotely.

  • IP authentication when working within your organization’s network.
  • with username/password or try via your institution
  • Persisted access using your organization’s identifier stored in your user browser for 90 days.
  • Contact us at AsktheExpert.AdisInsight@springer.com for assistance.

If your organization does not have a subscription to this content. To gain full access to the content and functionality of the AdisInsight database try one of the following.

  • Contact your organization’s admin about adding this content to your AdisInsight subscription
  • Buy a PDF version of the profile.
  • Request a free trial
Legal
Back to top