Collegium Pharmaceutical, Inc., a specialty pharmaceutical company, 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.
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."
About DETERx™
DETERx™ is a proprietary tamper resistant, extended release delivery platform that can be applied to drugs prone to abuse as well as drugs that have a narrow therapeutic window in which the inadvertent destruction of the time release system (crushing, breaking, chewing) can cause harm to a patient. The Company's DETERx™ platform consists of a multi-particulate matrix formulation in a capsule and is covered by a patent that expires in 2025. While developed primarily to provide tamper resistant, extended release properties, the multi-particulate design has the potential to allow patients with difficulty swallowing to open the capsule and administer the contents on food or with water, while maintaining the extended release properties of the product. In addition to COL-003 and COL-172, the Company has a number of additional DETERx ™ product candidates in development for the treatment of pain and ADHD.
Source
Collegium Pharmaceutical
View drug information on Oxycodone and Aspirin.
Комментариев нет:
Отправить комментарий