September 02, 2016

FDA Approves New Drug that Combats Misuse and Abuse of Opioids

, Legislation


The U.S. Food and Drug Administration (FDA) recently approved Troxyca ER, an extended-release, abuse-deterrent formulation of oxycodone and naltrexone.

Manufactured by Pfizer, Troxyca ER is a Schedule II taken in the form of an extended-release capsule for management of acute pain. At this time, it is not intended for first-time pain management opioid users, but rather injured workers who have not responded to other treatment options.

It is an opioid agonist/opioid antagonist combination that is indicated for continual maintenance treatment of severe pain. This means that while part of the active ingredients relieve pain, another part stops the euphoric aspect of the opioid, therefore making it harder to tamper with and misuse the oxycodone.

Previously, there have been six other abuse deterrents approved by the FDA.

Currently, there is no release date, as it can take several months from the time a new drug is approved by the FDA to when it can be placed on the market based on the necessary approvals required by various regulations and guidelines.

CorVel views Troxyca ER as another useful tool ensuring the safety of our claimants needing pain relief while recovering from injuries. Because pricing information has not yet been established, it is hard to fully gauge how much this product may change the landscape. However, with opioid narcotics representing over 28% of CorVel’s pharmacy spend, we expect this product to enter the mix of the most popular prescribed products.

CorVel’s pharmacy team is trained to ensure candidates are appropriately mapped for this drug. Within their system, qualifying patients will be identified in order to effectively mitigate risks. Additionally, the pharmacy team is knowledgeable as to how each of the 50 states is regulated and maintains a proactive approach when managing pharmacy programs. This strategy includes continually updating formularies and reviewing all opioids after 60 days in order to monitor the safety of CorVel’s patients.

We will continue to provide updates as more information becomes available.

If you have questions, or would like to learn more, contact a CorVel associate.