A Single-center, Randomized, Double-blind, Active- and Placebo Controlled, 5-way Crossover Study Assessing the Abuse Potential of Intranasally Administered VYCAVERT Tablets in Non-dependent Recreational Opioid Users
Phase of Trial: Phase II
Latest Information Update: 15 Aug 2014
At a glance
- Drugs Hydrocodone/paracetamol (Primary) ; Hydrocodone; Paracetamol
- Indications Pain
- Focus Pharmacodynamics; Registrational
- 26 Aug 2013 Primary endpoint 'Drug cravings' (subject like/dislike scores) has not been met according to an Acura Pharmaceuticals media release.
- 26 Aug 2013 Primary endpoint 'Drug-cravings' has not been met.
- 26 Aug 2013 Acura Pharmaceuticals will further evaluate trial results with plans to meet with the US FDA for discussion. The NDA submission will likely be delayed as a consequence of failure to demonstrate statistical significance for the primary endpoint.