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?

A randomized, double-blind, positive-controlled Phase 3 bridging study in subjects with moderate to severe acute pain after abdominal surgery to evaluate the analgesic efficacy and safety of OLINVYK compared with IV morphine in China

Next Previous
Trial Profile

A randomized, double-blind, positive-controlled Phase 3 bridging study in subjects with moderate to severe acute pain after abdominal surgery to evaluate the analgesic efficacy and safety of OLINVYK compared with IV morphine in China

Status: Recruiting
Phase of Trial: Phase III

Latest Information Update: 01 Feb 2022

Price :
$35 *
Note:
  • 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 Oliceridine (Primary) ; Morphine
  • Indications Postoperative pain
  • Focus Registrational; Therapeutic Use
  • Sponsors Jiangsu Nhwa Pharmaceutical

Most Recent Events

  • 27 Jan 2022 According to a Trevena media release, based on the data from two clinical bridging studies in Chinese patients, the China's National Medical Products Administration (NMPA) has accepted submission of a New Drug Application (NDA) for oliceridine injection for use in adults for the management of acute pain severe enough to require an intravenous opioid analgesic and for whom alternative treatments are inadequate. The NDA was submitted by Trevena's partner, Jiangsu Nhwa Pharmaceutical.
  • 08 Jul 2021 According to a Trevena media release, Following study completion, Nhwa expects to have sufficient clinical data, accompanied by Trevena's existing clinical data, to submit OLINVYK for NDA regulatory approval in China.
  • 08 Jul 2021 According to a Trevena media release, the first patient has been enrolled in the study.

You need to be a logged in or subscribed to view this content

Request demo (opens in a new window)
If your organization or you do not have a subscription, try one of the following: If your organization has a subscription, there are several access options, even while working remotely:
  • Working within your organization’s network
  • with username/password or try to via your institution
  • Persisted access using your organization’s identifier stored in your user browser for 90 days
Back to top