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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.

Citation:

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. http://www.prnewswire.com/news-releases/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-300445964.html. Accessed May 16, 2017.

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