Pfizer Nabs FDA Approval for Troxyca ER Capsules to Treat Pain

August 23, 2016

The FDA has approved Pfizer’s Troxyca extended-release capsules for oral use in patients who require long-term opioid treatment to manage severe pain.

Troxyca is the first oxycodone to feature oral abuse-deterrent properties in its labeling, according to Pfizer.

In total, the FDA has approved six extended-release tablets with abuse-deterrent labels based on properties that include a resistance to crushing for intranasal abuse or low oral bioavailability to deter oral abuse.

The approval announced late Friday was based on two pivotal clinical trials and four abuse-deterrent studies, which demonstrated that the therapy can treat pain for up to 12 months and possesses significant barriers to extract the oxycodone and naltrexone HCI in the capsules.

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