More information continues to be shared in regard to this week’s groundbreaking federal approval of the medication Vivitrol to prevent relapse to opioid addiction:
Drug maker Alkermes, Inc. says it sees overlap between physicians it has targeted for use of Vivitrol in treating alcohol dependence and those who prescribe medication for opioid dependence. So receiving the new indication for opioid treatment should not be interpreted as leading to an abandonment of the alcohol treatment market. The company stated in an e-mail response to a question we posed today, “Vivitrol for alcohol dependence continues to be a focus for us.”
The Phase III study that led to the FDA approval of the opioid dependence indication found the most common adverse events seen in the Vivitrol patient group were liver enzyme elevations, nasopharyngitis and insomnia. The medication was generally well-tolerated. Commenting on the often-discussed issue of injection site complications from the injectable medication, the company stated that “there is information in our medication guide to educate healthcare providers on proper injection technique.”
Finally, Alkermes CEO Richard Pops emphasized in this morning’s post-approval conference call that this approval of a new medication option could help lead to more research on which types of patients are best suited for a particular medication for opioid dependence, and why. Such data could go a long way toward improving medication outcomes overall, and enhancing medications’ credibility to an often skeptical treatment population.