The FDA has accepted Collegium Pharmaceutical Inc's investigational new drug application to begin a clinical trial for Hydrocodone DETERx.
The FDA has accepted Collegium Pharmaceutical Inc’s investigational new drug application to begin a clinical trial for Hydrocodone DETERx.
The abuse-deterrent, extended-release analgesic is designed to treat chronic pain.
The clinical trial will be geared toward establishing the safety, bioavailability, and abuse deterrence properties of Hydrocodone DETERx.
“We believe that Hydrocodone DETERx has the potential to provide similar advantages and unique product characteristics as our lead product, Xtampza ER,” said Ernest Kopecky, vice president of clinical development at Collegium, in a press release. “These features include abuse-deterrent properties that may decrease oral abuse, intranasal abuse, and abuse by injection.”
DETERx combines its active ingredients with fatty acid and waxes to create small microspheres. These microspheres fill capsules and help with the resistance of breaking, crushing, chewing, and dissolving pills.
“Hydrocodone DETERx has met our in vitro screens for both abuse-deterrent and drug release characteristics” said Michael Heffernan, CEO of Collegium, in a press release. “The commencement of this study marks another milestone for Collegium following the FDA tentative approval of our lead product candidate, Xtampza ER. Upon successful completion of this clinical trial, we intend to accelerate development of this pipeline product.”