Collegium Pharmaceutical, Inc., a specialty pharmaceutical company, today announced that the U.S. Food and Drug Administration (FDA) has granted Fast Track designation to the investigation of COL-172 for the relief of moderate to severe pain in patients requiring continuous, around-the-clock opioid treatment for an extended period of time. COL-172, a tamper resistant, extended release oral opioid formulation, is the Company's second product candidate incorporating its proprietary DETERx™ technology for which it has filed an IND application. The Company's lead product candidate, COL-003, is currently in late stage clinical development and has also been granted Fast Track Designation by the FDA.
“We are pleased that the FDA has recognized that our second product candidate incorporating our DETERx™ delivery technology, COL-172, may fulfill the significant public health need for a tamper resistant, extended release opioid product, as evidenced by the Fast Track designation.”
The FDA's Fast Track Drug Development Program is designed to facilitate the development and expedite the review of new drugs that are intended to treat serious or life-threatening conditions and that demonstrate the potential to address unmet medical needs. Fast track designated products ordinarily qualify for priority review, thereby expediting the FDA review process.
The rationale for the investigation of COL-172 as a Fast Track development program stems from the well documented issues associated with the misuse and abuse of opioid products, and in particular extended-release formulations of these drugs. Extended release opioid formulations are very effective for the treatment of pain in chronic patients when used correctly and according to the product label but can be 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 unintended harmful effects when used by legitimate patients.
"Extended release opioids remain a very valuable treatment option for patients who suffer from chronic pain. Our goal at Collegium is to incorporate advanced drug delivery technologies such as DETERx™ to many of the commonly available opioid compounds in order to maintain the clinical utility, while at the same time lessen the chance for misuse via tampering," stated Michael Heffernan, President, Collegium Pharmaceutical. "We are pleased that the FDA has recognized that our second product candidate incorporating our DETERx™ delivery technology, COL-172, may fulfill the significant public health need for a tamper resistant, extended release opioid product, as evidenced by the Fast Track designation."
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