CUMBERLAND, R.I.--(BUSINESS WIRE)-- Collegium Pharmaceutical, Inc., a specialty pharmaceutical company, announced today that it has successfully completed a Type A meeting with the U.S. Food and Drug Administration (FDA) regarding the proposed Phase III clinical study for COL-003, the Company’s tamper-resistant, extended release oxycodone product utilizing its proprietary DETERx™ technology. The Company obtained specific guidance on the study design as well as agreement to proceed with its proposed Phase III clinical program, which will investigate the safety and efficacy of COL-003 in a single 12-week, placebo-controlled study in opioid naïve and experienced patients with chronic low back pain.
“We are pleased to announce the successful outcome of our recent meeting with the FDA. We believe that with the on-going national epidemic of prescription drug abuse there remains a significant unmet clinical need for tamper-resistant formulations to mitigate abuse/misuse of opioid products. We are currently preparing to commence the Phase III trial for COL-003 and are working to complete the remaining development activities required for regulatory submission”, stated Michael Heffernan, President, Collegium Pharmaceutical.
The DETERx™ drug delivery platform consists of a multi-particulate matrix formulation in a capsule. While developed primarily to provide tamper resistant properties to protect against common methods of tampering such as chewing, crushing, injecting, snorting and extraction for IV injection, the multi-particulate design also potentially enables patients with difficulty swallowing to open the capsule and administer the contents on food or with water, while maintaining the sustained release properties of the product. The formulation platform is covered by existing and pending US and international patents and patent applications.
In addition to COL-003, Collegium has also filed an IND for COL-172, its second candidate for the treatment of chronic pain. Both COL-172 and COL-003 have been granted Fast Track Designation by the FDA.
About Collegium Pharmaceutical
Collegium Pharmaceutical, Inc. is a specialty pharmaceutical company focused on the development of proprietary, late stage pharmaceutical products. These products target market opportunities through formulation based product improvements protected by intellectual property (IP). Collegium is focused on building a portfolio of pain products that incorporate its patent protected DETERx™ formulation platform that provides for extended release and tamper resistance. For more information, visit the Company’s website at www.collegiumpharma.com.
Collegium Pharmaceutical, Inc.Michael Heffernan, 401-762-2000 Ext. 220Presidentmheffernan@collegiumpharma.com