Following the submission of its investigational new drug (IND) application to the Food and Drug Administration (FDA), the New Jersey-based company says it is now preparing for a phase I/II, open label study of its naltrexone implant in healthy volunteers with a history of opioid abuse.
The specialty drug maker said the primary objective of the study using the subdermal implant is to investigate the extent of opiate blockade following morphine challenges.
“At this stage of development, it is not possible to predict with certainty the duration of time over which our naltrexone implant will deliver a therapeutic dose of the active agent,” said Dr David Tierney, president and CEO at Valera.
“However, our goal is an implant that can provide controlled release of naltrexone for three to six months. We believe such a product would offer significant advantages over the currently approved daily oral formulation of naltrexone for treating opioid dependence, particularly with regard to patient compliance,” he added.