FDA Approves New Opioid, RoxyBond (oxycodone hydrochloride)

FDA Approves New Opioid, RoxyBond (oxycodone hydrochloride)

The FDA has approved RoxyBond (oxycodone hydrochloride) tablets for the management of pain severe enough to require an opioid analgesic and for which alternative treatments are inadequate.

RoxyBond will be available in 5mg, 15mg and 30mg tablets, with a dosing range of every 4-6 hours as needed for pain.

Because of the risks of addiction, abuse, and misuse with opioids, even at recommended doses, RoxyBond should be reserved patients for whom alternative treatment options (e.g., non-opioid analgesics or non-opioid combination products):

  • Have not been tolerated or are not expected to be tolerated
  • Have not provided adequate analgesia or are not expected to provide adequate analgesia

For further information, read the FDA label or approval letter.