Collegium Pharmaceutical files IND for second opioid product using DETERx technology

Collegium Pharmaceutical, Inc., a specialty pharmaceutical company, today announced that it has filed an Investigational New Drug (“IND”) application for COL-172, a tamper-resistant, extended-release oral opioid formulation intended to treat moderate to severe pain in individuals who require around-the-clock opioid therapy for an extended period of time. 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. This IND filing follows the previous filing of the Company’s lead 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.

“We are very pleased to be advancing another product candidate into clinical development using our DETERx™ technology”

Data from the National Survey on Drug Use and Health suggests that non-medical use of prescription pain relievers is a serious public health problem, with an estimated 2.2 million new non-medical users aged 12 or older in 2008. The same publication also reported that the problem continues to grow in the US. From 2002 to 2008, the rate of current non-medical use of prescription pain relievers had increased among young adults aged 18 to 25.

Extended release opioid formulations are particularly attractive targets for non-medical use, since the time-release mechanism of most currently marketed products can be defeated by chewing, crushing or dissolving the formulation in water, rendering the full dose of drug immediately available if ingested orally, snorted or injected. Such “formulation tampering” is believed to be widely prevalent. The Company’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 the Company’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.

"We are very pleased to be advancing another product candidate into clinical development using our DETERx™ technology”, stated Michael Heffernan, President, Collegium Pharmaceutical. “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.”