A two-stage trial evaluating single- and multiple-dose pharmacokinetics of benzhydrocodone/paracetamol [KP 201] in volunteers
Phase of Trial: Phase I
Latest Information Update: 05 May 2016
At a glance
- Drugs Benzhydrocodone/paracetamol (Primary)
- Indications Acute pain
- Focus Pharmacokinetics; Registrational
- 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.
- 10 Mar 2016 According to a KemPharm media release, the company has submitted an NDA under the 505(b)(2) regulatory pathway to the US FDA. The FDA has accepted the NDA, granted priority review and assigned a PDUFA date of June 9, 2016.
- 12 Nov 2015 According to KemPharm Inc. media release, In May 2015 the company obtained guidance in a pre-NDA meeting with the FDA.