Drugs

FDA Approves Inspirion Abuse-deterrent Oxycodone

FDA has approved Inspirion Delivery Sciences’ RoxyBond (oxycodone hydrochloride) tablets, indicated for managing pain severe enough to require an opioid analgesic and for which alternative treatments are inadequate. The company describes RoxyBond as 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 manufactured with physical and chemical barriers to deter abuse, without the use of aversive agents or opioid antagonists, the company says. For example, it uses Inspirion’s SentryBond technology and 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 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,” the company says. “In addition, both intact and manipulated RoxyBond tablets resisted extraction in selected household and laboratory solvents under various conditions, including selected pre-treatments.”

On 4/5, a joint meeting of the Anesthetic and Analgesic Drug Products Advisory Committee and Drug Safety and Risk Management Advisory Committee voted 19 to 0 to recommend the product’s approval.

Gupta Raises Concerns About Overton’s Independence, Ideology

FDA commissioner nominee Heidi Overton’s responses on vaccines, contraception and abortion medication during her 9/24 Senate confirmation hearing raise concerns that ideology could influence her decision-making if she takes over the agency, MSNBC senior medical analyst Dr. Vin Gupta said Friday. Gupta was particularly critical of Overton’

Overton Confirmation Remains Uncertain After Senate Hearing

FDA commissioner nominee Heidi Overton emerged from her Senate confirmation hearing Thursday (see earlier story) without resolving questions about whether she has enough Republican support to advance — and with a rapidly narrowing window for confirmation before the midterm elections. The Senate Health, Education, Labor and Pensions Committee hearing provided few

FDA Classifies Boston Scientific Imager II Catheter Recall as Class I

FDA has classified Boston Scientific's recall of its Imager II Angiographic Catheters as Class I because a manufacturing problem could cause catheter tips to degrade and detach, potentially resulting in life-threatening complications. The agency announced the Class I classification 9/25, updating an Early Alert it issued

FDA Approves Gazyva for Childhood-Onset Idiopathic Nephrotic Syndrome

FDA has approved Roche’s Gazyva (obinutuzumab) for reducing the risk of relapse in adults and children aged 2 and older with frequently relapsing or steroid-dependent, childhood-onset idiopathic nephrotic syndrome who are in remission. The expanded approval covers the use of the CD20-directed antibody beyond its existing

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Gupta Raises Concerns About Overton’s Independence, Ideology

Overton Confirmation Remains Uncertain After Senate Hearing

FDA Classifies Boston Scientific Imager II Catheter Recall as Class I

FDA Approves Gazyva for Childhood-Onset Idiopathic Nephrotic Syndrome