The filing of the IND follows a successful Pre-IND meeting with the FDA, during which guidance was provided to the company regarding the basis of approval and the product development plan. COL-172 is the second product candidate incorporating the DETERx technology for which the company has filed an IND application.
The IND filing follows the previous filing of the company’s product candidate, COL-003, a tamper-resistant, extended-release formulation of oxycodone, which is currently under clinical development and has been granted Fast Track Designation by the FDA.
Collegium’s DETERx delivery technology consists of a multi-particulate matrix formulation in a capsule, designed to be less susceptible than conventional formulations to common methods of tampering and physical manipulation without relying on aversive agents or pharmacological approaches that could have harmful effects in legitimate patients.
COL-172 has met Collegium’s internal pre-clinical endpoints and is in the process of being moved into clinical development. The company also has developed a number of additional product candidates using the DETERx platform.
Michael Heffernan, president of Collegium Pharmaceutical, said: “We are pleased to be advancing another product candidate into clinical development using our DETERx technology. The continued development of COL-172 validates the versatility of the DETERx platform in providing both extended release and tamper resistance across a variety of active pharmaceutical ingredients.
“Based on the feedback obtained from the FDA in our Pre-IND meeting, we feel that we have a clear understanding of the regulatory requirements necessary for the approval of COL-172.”