Protega Pharmaceuticals Inc., a unique specialty pharmaceutical company dedicated to ethical pain control and creating new abuse-resistant products, revealed that the US Food and Drug Administration (FDA) has given the green light for Roxybond (oxycodone hydrochloride) immediate-release (IR) CII 10 mg tablet to be used for treating severe pain that necessitates an opioid analgesic and when other therapies are not effective. Roxybond is the initial and sole FDA-approved abuse-deterrent IR 10 mg oxycodone formulation designed to decrease abuse through intranasal and intravenous methods.
Roxybond is developed using SentryBond technology designed to deter abuse. This patented technology mixes non-active components with active pharmaceutical ingredients in order to make it harder to misuse and abuse the tablet, even when it is physically or chemically tampered with. SentryBond is created to uphold the planned release schedule of extended-release (ER) items and postpone the release of IR items.
"The FDA approval of Roxybond 10 mg with SentryBond is a significant milestone for Protega and fulfills an unmet need for an IR opioid with abuse-deterrent technology that may reduce misuse and abuse while providing pain relief to medically appropriate patients when used as indicated," said Paul Howe, chief commercial officer of Protega. "When manipulated, our innovative technology renders the pill more difficult to misuse or abuse, such as being cut or crushed to snort or inject."
, CDSCO.jpg)
