FDA accepts Collegium's opioid product IND

Rhode Island, USA-based specialty drug firm Collegium Pharmaceutical says that the Investigational New Drug Application for its patent-pending, abuse deterrent, sustained release, oral opioid formulation COL-003 is now active following its acceptance by the Food and Drug Administration. The company submitted the IND in June.

A proof-of-concept clinical trial will be initiated immediately. This is designed to assess the safety and pharmacokinetics of various formulations of COL-003 compared to a currently-marketed product used as a control and with COL-003 consumed after chewing, a common route of misuse of sustained release opioids. The study is designed as an open label, controlled, crossover comparison in healthy subjects.

COL-003 utilizes Collegium's DETERx technology and is a sustained-release oral dosage form designed to be more resistant to tampering and abuse than traditional formulations of the drug. This product has undergone extensive in vitro testing and preclinical development and has met its endpoints for dissolution and in vitro abuse simulation testing. Based on these studies the product is expected to be beneficial in deterring abuse by oral administration (eg, chewing, crushing), intravenous injection and nasal administration (ie, snorting).