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: 05 May 2016
At a glance
- Drugs Benzhydrocodone/paracetamol (Primary) ; Hydrocodone/paracetamol
- Indications Pain
- Focus Adverse reactions
- Sponsors KemPharm
- 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.
- 19 Feb 2016 Results published in the KemPharm Inc. media release.