Collegium Pharmaceutical, Inc. Announces Filing of IND for Second Chronic Pain Product Using DETERx(TM) Tamper-Resistant, Extended Release Technology
3/26/2010 10:08:13 AM
CUMBERLAND, R.I.--(BUSINESS WIRE)--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.