Clinical Edge

Summaries of Must-Read Clinical Literature, Guidelines, and FDA Actions

FDA Approves RoxyBond for Severe Pain

Inspirion Delivery Sciences, LLC news release; 2017 Apr 26

Inspirion Delivery Sciences, LLC ("Inspirion") has announced that the US 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. Inspirion Delivery Sciences, LLC is headquartered in Basking Ridge, NJ.

Indications: RoxyBond should be reserved for use in patients for whom alternative treatment options (eg, non-opioid analgesics or opioid combination products) have not been tolerated or are not expected to be tolerated, or have not provided adequate analgesia or are not expected to provide adequate analgesia.

Dosage/administration: RoxyBond tablets are available in 3 strengths: 5 mg, 15 mg, and 30 mg. It is recommended that patients use the lowest effective dosage for the shortest duration consistent with individual patient treatment goals. Initiate dosing with a range of 5 to 15 mg every 4 to 6 hours as needed for pain.

Adverse effects: Most common adverse reactions include nausea, constipation, vomiting, headache, pruritus, insomnia, dizziness, asthenia, and somnolence.


Inspirion Delivery Sciences receives FDA approval for RoxyBond™ (oxycodone hydrochloride) tablets CII, the first and only immediate release opioid analgesic with abuse-deterrent label claims. [news release]. Basking Ridge, New Jersey: Inspirion Delivery Sciences, LLC. April 26, 2017. Accessed May 16, 2017.

This Week's Must Reads

Possible Link: Hepatic Steatosis and Brain Aging, JAMA Neurol; ePub 2017 Nov 20; Weinstein, et al

Neurologic Drug Shortages May Compromise Care, Neurology; ePub 2017 Nov 15; Omorodion, et al

Sleep Fragmentation Linked with PD in Older Adults, Mov Disord; ePub 2017 Oct 30; Sohail, Yu, et al

Dietary Sodium to Potassium Ratio and Stroke Risk, Stroke; ePub 2017 Oct 10; Willey, Gardener, et al

Sleep Apnea Did Not Accelerate Kidney Decline, Sleep; ePub 2017 Nov 3; Canales, Hagen, et al

Must Reads in FDA Actions

FDA Clears Apple Watch Heart Rate Accessory, PharmaLive news release; 2017 Nov 30

FDA Approves Soliris for Generalized MG, Alexion news release; 2017 Oct 23

FDA Approves Lyrica CR Extended-Release Tablets CV, Pfizer news release; 2017 Oct 12