Collegium Pharmaceutical, Inc. announced that the U.S. Food and Drug Administration (FDA) has accepted the Company’s investigational new drug (IND) application to begin a clinical trial of Hydrocodone DETERx®, an abuse-deterrent, extended-release analgesic for the treatment of chronic pain. This proof of concept clinical trial is intended to evaluate the safety, bioavailability, and abuse deterrence properties of Hydrocodone DETERx.
“Hydrocodone DETERx has met our in vitro screens for both abuse-deterrent and drug release characteristics” said Michael Heffernan, CEO of Collegium. “The commencement of this study marks another milestone for Collegium following the FDA tentative approval of our lead product candidate, Xtampza™ ER (Oxycodone DETERx). Upon successful completion of this clinical trial, we intend to accelerate development of this pipeline product.”
“We believe that Hydrocodone DETERx has the potential to provide similar advantages and unique product characteristics as our lead product, Xtampza ER. These features include abuse-deterrent properties that may decrease oral abuse, intranasal abuse, and abuse by injection. Hydrocodone DETERx may provide physicians, once approved, with another abuse deterrent analgesic for the management of patients with chronic pain,” said Dr. Ernest Kopecky, Vice President, Clinical Development. “In addition, the microsphere-in-capsule, oral formulation will be able to be sprinkled directly into the mouth, sprinkled onto soft foods, or delivered via feeding tubes.”
