April 27, 2016
Xtampza (oxycodone) extended-release (ER) capsules CII (Xtampza ER) has been approved by the US Food and Drug Administration for the treatment of pain severe enough to require daily, around-the-clock, long-term opioid treatment or for circumstances where alternative treatment options may be inadequate.
Xtampza ER utilizes a new proprietary design called DETERx that allows it to maintain its drug release profile even if it has been chewed or crushed prior to administration. This can make it far easier for physicians to administer the drug to patients who may have difficulty swallowing by allowing them to sprinkle it on soft foods, into a cup, or through a gastrostomy or nasogastric feeding tube. All of these methods of administration are supported by the drug’s label.
In addition, Xtampza ER’s patented design may be an effective method of preventing abuse or misuse of opioids common in other drug types. “Our lead product completed an extensive battery of abuse-deterrent testing consistent with the FDA Guidance on Abuse-Deterrent Opioids,” explained Michael Heffernan, CEO of Collegium, the company that produces the drug.
Collegium expects to launch Xtampa ER in the United States in mid-2016. The drug will be offered in five dosage strengths equivalent to 10 mg, 15 mg, 20 mg, 30 mg, and 40 mg oxycodone hydrochloride.—FRMC Editor