FDAnews
www.fdanews.com/articles/86509-javelin-reports-intranasal-ketamine-trial-data

JAVELIN REPORTS INTRANASAL KETAMINE TRIAL DATA

May 2, 2006

Javelin Pharmaceuticals has announced the preliminary results of a randomized, placebo- controlled pilot Phase II study with intranasal Ketamine in 60 patients with moderate-to-severe pain following bunion surgery.

Treatment with intranasal Ketamine was well-tolerated. There were no unexpected or serious adverse events related to the study drug. Local adverse events associated with nasal administration (throat irritation, oral discomfort, oral hypoaesthesia, rhinorrhea) were more common in the intranasal Ketamine treatment groups. General adverse events that were reported more frequently for the active drug treatment group included dizziness, dysgeusia and somnolence.