Trial Profile

A pivotal bioequivalence trial of buprenorphine/naloxone in patients with opioid dependence.

Status: Completed

Phase of Trial: Phase III

Latest Information Update: 25 Mar 2015

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 Buprenorphine/naloxone (Primary)
Indications Opioid-related disorders
Focus Pharmacokinetics; Registrational

Most Recent Events

16 Mar 2015 A sNDA submission is anticipated by the fourth quarter of 2015, according to a BioDelivery Sciences International media release.
07 Aug 2013 Based on outcomes of this trial, and one other trial, an NDA was submitted to the FDA for BUNAVAIL [buprenorphine/naloxone], according to a BioDelivery Sciences International media release issued on 1 August 2013.
22 Jan 2013 Tolerability results have been reported in a BioDelivery Sciences International media release.

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

If your organization or you do not have a subscription, try one of the following:

Contacting your organization’s admin about adding this content to your AdisInsight subscription
Buying a PDF version of any individual profile
Request a free trial

If your organization has a subscription, there are several access options, even while working remotely:

Working within your organization’s network
Login with username/password or try to access via your institution
Persisted access using your organization’s identifier stored in your user browser for 90 days

For assistance, contact us at asktheexpert.adisinsight@springer.com