Valera files IND for its subdermal implant for treatment of opioid addiction

By Lisa Kerner

Charlotte, N.C., June 27 - Valera Pharmaceuticals, Inc. submitted an Investigational New Drug application to the Food and Drug Administration for VP004, a subdermal implant using the company's Hydron technology to deliver naltrexone, for the treatment of opioid addiction.

In addition, Valera said it is preparing for a phase 1/ 2, open label study of its naltrexone implant in healthy volunteers with a history of opioid abuse.

"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," president and chief executive officer David S. Tierney said in a company news release.

"However, our goal is an implant that can provide controlled release of naltrexone for three to six months."

Naltrexone is a potent opioid receptor antagonist that binds to receptors in the brain, blocking the euphoric effects produced by opioids.

Valera develops, acquires and commercializes products to treat urology and endocrinology diseases and disorders.

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