Collegium Pharmaceutical has submitted a new drug application (NDA) to the US Food and Drug Administration (FDA) for Xtampza ER, its oxycodone extended-release (ER), abuse-deterrent analgesic using its DETERx technology platform, to treat chronic pain.
The submission is based on results from Phase III trial, which 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 NDA is also based on 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abuse-deterrent development program that followed the FDA’s ‘Abuse-Deterrent Opioids – Evaluation and Labeling’ draft guidance published in January 2013.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 Xtampza ER abuse-deterrent program included a series of in vitro, pharmacokinetic and human abuse potential (HAP) trials.
Additionally, the company has completed all of the necessary trails to support proposed product labeling, which will instruct patients with difficulty swallowing (dysphagia) to administer the capsule contents directly into their mouth; onto food; or via feeding tube.
If Xtampza ER gets approval, it could be the only abuse-deterrent oxycodone product to provide patients with difficulty swallowing an administration option of sprinkling the capsule contents directly into the mouth or onto soft foods without compromising the integrity of the ER profile.
Collegium CEO Michael Heffernan said: "This FDA submission represents a major step toward offering the first extended-release, abuse-deterrent oxycodone product that not only resists common forms of abuse, but also provides an administration option for patients with concurrent chronic pain and difficulty swallowing pills.
"Filing the Xtampza ER NDA is an important milestone in our continued efforts to develop a portfolio of abuse-deterrent pain medications designed to address unmet societal needs."
The DETERx drug delivery platform includes a microsphere-in-capsule formulation and it is designed to offer abuse-deterrent properties to protect against common methods of tampering.
The microsphere design will allow patients with difficulty swallowing to open the capsule and administer the contents onto food or via feeding tube, while maintaining the ER properties of the product.