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FDA Approves RoxyBond

Inspirion Delivery Sciences Receives FDA Approval for RoxyBond (oxycodone hydrochloride) Immediate Release Tablets with Abuse-Deterrent Label Claims

BASKING RIDGE, N.J., April 26, 2017 /PRNewswire/ -- Inspirion Delivery Sciences, LLC ("Inspirion") announced that the United States Food and Drug Administration (FDA) has approved RoxyBond™ (oxycodone hydrochloride) tablets, for oral use, CII, indicated for the management of pain severe enough to require an opioid analgesic and for which alternative treatments are inadequate. RoxyBond is an abuse-deterrent formulation of oxycodone that uses physical and chemical barriers to deter abuse, without the use of aversive agents or opioid antagonists. RoxyBond is the first immediate-release opioid analgesic approved with labeling describing its abuse-deterrent properties, consistent with the FDA's 2015 Guidance for Industry: Abuse-Deterrent Opioids – Evaluation and Labeling. RoxyBond is approved in three dosage strengths: 5, 15, and 30mg.

RoxyBond, which uses Inspirion's SentryBond™ technology, is formulated with inactive ingredients that make the tablet more difficult to manipulate for misuse and abuse even if the tablet is subjected to physical manipulation and/or attempts at chemical extraction. Laboratory test data demonstrated that, relative to another approved oxycodone immediate-release tablet, RoxyBond has increased resistance to cutting, crushing, grinding, or breaking using selected tools. In addition, both intact and manipulated RoxyBond tablets resisted extraction in selected household and laboratory solvents under various conditions, including selected pre-treatments. Relative to oxycodone immediate-release tablets, the RoxyBond formulation forms a viscous material that resists passage through a needle; it was also more difficult to prepare solutions suitable for intravenous injection. The in vitro data demonstrate that RoxyBond has physicochemical properties expected to make abuse via injection difficult. However, abuse by the intranasal, oral, and intravenous route is still possible.

A clinical abuse potential study was also conducted. "As reflected in the prescribing information, the data from the clinical study, along with support from in vitro data, also indicate that RoxyBond has physicochemical properties that are expected to reduce abuse by the intranasal route of administration," said Lynn R. Webster, MD, Principal Investigator, PRA Health Sciences, Salt Lake City, UT.

"RoxyBond represents the first and only immediate-release opioid approved by FDA with abuse-deterrent claims," said Jeffrey Gudin, MD, Department Director, Pain Management Center Englewood Hospital and Medical Center. Dr. Gudin went on to say, "Oxycodone immediate release opioid tablets are widely abused and the development of RoxyBond will offer clinicians a new approach for treating patients in pain while also fighting against the potential for abuse."

"Inspirion is pleased to receive FDA approval for our second abuse deterrent product, RoxyBond, which is intended to address the long standing unmet need for immediate release abuse deterrent opioids. There are nearly 18 million prescriptions for immediate release oxycodone hydrochloride annually in the U.S. alone." said Stefan Aigner, MD, CFA, CEO of Inspirion.

On April 5, 2017, a joint meeting of the Anesthetic and Analgesic Drug Products Advisory Committee and Drug Safety and Risk Management Advisory Committee of the U.S. Food and Drug Administration voted 19 to 0 (with one abstention) to recommend approval of RoxyBond.

About Inspirion Delivery Sciences, LLC

Inspirion Delivery Sciences LLC is a privately held specialty pharmaceutical company that is dedicated to advancing solutions in the field of prescription drug abuse deterrence through continued innovation. Recognizing the serious unmet public health need to combat the escalating crisis of prescription opioid abuse and misuse, Inspirion began pioneering the development of novel abuse-deterrent technologies. For more information, visit the Company's website at www.inspirionds.com.

About SentryBond™

The SentryBond technology platform combines inactive excipients with active pharmaceutical ingredients (API) in a tablet that is specifically designed to frustrate abuse for various methods of manipulation and routes of administration while slowing of the intended immediate-release properties of RoxyBond when manipulated then insufflated compared to taking RoxyBond orally intact. SentryBond Technology imparts its abuse-deterrent characteristics via physical and chemical methods, without the use of antagonist or aversive agents. SentryBond technology is covered by an issued U.S. patent, with multiple U.S. and global patent applications pending.

Source: Inspirion Delivery Sciences, LLC

Posted: April 2017

RoxyBond (oxycodone hydrochloride) FDA Approval History

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