FDA Approves Protega’s 10 mg Abuse-Deterrent Opioid Roxybond for Pain Management

FDA Approval:
The U.S. Food and Drug Administration (FDA) has approved Protega Pharmaceuticals' 10 mg immediate-release (IR) tablet of Roxybond (oxycodone hydrochloride) for pain management.

Abuse-Deterrent Technology:
Roxybond is formulated with SentryBond abuse-deterrent technology, which makes the tablet more difficult to manipulate for misuse and abuse.

Indication:
Roxybond is indicated for the management of pain severe enough to require an opioid analgesic and for which alternative treatments are inadequate.

Dosage Forms:
Roxybond is now available in 5 mg, 10 mg, 15 mg, and 30 mg tablets, providing clinicians with a range of dosing options for pain management.

Safety and Efficacy:
The approval is based on extensive testing, including over 2000 in vitro tests and human abuse potential studies, which suggest that Roxybond's physicochemical properties are expected to reduce abuse via intranasal and intravenous routes.

Launch Plans:
Protega plans to launch Roxybond 10 mg before the end of the year, enhancing flexibility and precision in opioid therapy for both physicians and patients.