Phase I single-centre, placebo-controlled abuse liability trial of orally administered benzhydrocodone/paracetamol (KP 201), compared with hydrocodone/paracetamol.
Phase of Trial: Phase I
Latest Information Update: 12 Sep 2017
At a glance
- Drugs Benzhydrocodone/paracetamol (Primary) ; Hydrocodone/paracetamol
- Indications Pain
- Focus Adverse reactions
- Sponsors KemPharm
- 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.
- 05 May 2016 According to a KemPharm media release, the Anesthetic and Analgesic Drug Products Advisory Committee and the Drug Safety and Risk Management Advisory Committee of the US FDA voted in favor of approval for benzhydrocodone/paracetamol hydrochloride combination (Apadaz) for the management of acute pain that requires opioid and voted against inclusion of abuse deterrent labeling for the product.
- 19 Feb 2016 According to a KemPharm Inc. media release, the U.S. FDA accepted New Drug Application for KP201/APAP and granted priority review. Under the the Prescription Drug User Fee Act the U.S. FDA has set a target action date of 9-June-2016.