Phase I abuse liability trial of intranasally administered benzhydrocodone/paracetamol (KP 201), compared with hydrocodone/paracetamol.
Phase of Trial: Phase I
Latest Information Update: 23 Feb 2018
At a glance
- Drugs Benzhydrocodone/paracetamol (Primary) ; Hydrocodone/paracetamol
- Indications Pain
- Focus Adverse reactions
- Sponsors KemPharm
- 23 Feb 2018 According to a KemPharm media release, the U.S. Food and Drug Administration (FDA) has approved New Drug Application (NDA) for Apadaz for the short-term (no more than 14 days) management of acute pain severe enough to require an opioid analgesic and for which alternative treatments are inadequate.
- 12 Sep 2017 According to a company media release, KemPharm has responded to the Complete Response Letter (CRL) received on June 13, 2016 by submitting an amended New Drug Application (NDA) for Apadaz. The FDA has notified the Company with the determination that the NDA application for Apadaz is complete and has assigned February 23, 2018 as the expected date by which an approval decision will be determined.
- 09 Sep 2016 According to a KemPharm media release, the results will be presented at the annual meeting PAINWeek 2016.
Most Recent Events
Table of Contents
- At a glance
- Trial Overview
- Trial Details
- Trial Centres
- Trial History