FDA approves Protega’s Roxybond

Privately-held US drugmaker Protega Pharmaceuticals says that the US Food and Drug Administration (FDA) has approved Roxybond (oxycodone hydrochloride) immediate-release (IR) CII 10mg tablet for the management of pain severe enough to require an opioid analgesic and for which alternative treatments are inadequate.

The New Jersey-based firm claims that Roxybond is the first and only FDA-approved abuse-deterrent IR 10mg oxycodone formulation that is expected to reduce abuse by intranasal and intravenous routes.

Roxybond is formulated with SentryBond abuse-deterrent technology. This patented technology combines inactive excipients with active pharmaceutical ingredients to make the tablet more difficult to manipulate for misuse and abuse, even if it is subjected to physical manipulation and/or chemical extraction. SentryBond is designed to maintain the intended release profile of extended-release (ER) products and delay the release of IR products.