COL-003 contains oxycodone as its active ingredient and utilizes the company’s DETERx technology. COL-003 has undergone extensive in vitro dissolution and tamper resistance testing as well as pharmacokinetic studies in healthy volunteers. In order to assess the tamper resistant qualities of the COL 003, one arm of the study included subjects that opened the capsule and chewed the contents prior to swallowing.
The study has demonstrated that the plasma profile for COL 003 when chewed was bioequivalent to COL-003 when administered whole and as intended, suggesting that attempting to breakdown the sustained release mechanism by chewing would not result in a meaningful increase in plasma level as desired by the abuser.
Based on the in vitro and in vivo studies, COL-003 is expected to provide adequate plasma concentrations to effectively treat pain while decreasing the effectiveness of tampering methods used to prepare conventional tablets for abuse via oral administration (chewing, crushing), intravenous injection and nasal administration (snorting).