Collegium Pharmaceutical files NDA with FDA for Xtampza ER
The FDA has accepted for filing Collegium Pharmaceutical’s NDA for Xtampza ER, its novel, abuse-deterrent, extended-release oxycodone formulation for the treatment of chronic pain. Collegium Pharmaceutical is a specialty pharmaceutical company focused on the development and commercialization of innovative abuse-deterrent treatments for chronic pain and other diseases
Xtampza ER is Collegium’s lead product candidate utilizing its proprietary DETERx technology platform, and is designed to maintain its extended-release profile after being subjected to common methods of tampering. The abuse-deterrent properties incorporated into the Xtampza ER formulation are designed to make it more difficult to manipulate for the purpose of abuse or misuse via common routes of administration including chewing, crushing and/or dissolving, and then taking orally, snorting, smoking or injecting.
“Collegium is committed to developing and commercializing a portfolio of products that address the epidemic of chronic pain and the growing problems associated with non-medical use, abuse and misuse of prescription products by leveraging our proprietary DETERx technology platform,” said Michael Heffernan, CEO of Collegium. “Upon approval, Xtampza ER has the potential to provide a novel treatment option to patients in need of chronic pain therapy.”
The NDA submission is based on a comprehensive development program including a pivotal phase III clinical trial and data from an extensive abuse-deterrent development program that followed the FDA’s Abuse-Deterrent Opioids—Evaluation and Labeling draft guidance published in January 2013.
The phase III clinical trial evaluated the safety, tolerability and efficacy of Xtampza ER compared with placebo in opioid-experienced and opioid-naïve subjects with moderate-to-severe chronic low back pain. The Xtampza ER abuse-deterrent program consisted of a battery of in vitro (laboratory-based), pharmacokinetic and human abuse potential studies. In addition, the NDA submission includes data from head-to-head abuse-deterrent studies (in vitro and pharmacokinetic) comparing Xtampza ER to OxyContin OP.
The DETERx technology platform consists of a microsphere-in-capsule formulation. While developed primarily to provide abuse-deterrent properties to protect against common methods of tampering such as chewing, crushing, insufflation, and extraction for IV injection, the microsphere design is intended to enable patients with difficulty swallowing to open the capsule and administer the contents onto food or via feeding tube, while maintaining the extended-release (ER) properties of the product.
The DETERx technology can be used with drugs that are commonly abused such as opioids and amphetamines, as well as drugs that have a narrow therapeutic index that would benefit from protection against misuse.