Alternative Modes of Administration Tested for Pain Drug Xtampza ER
Collegium announced the publication of results from the study “An Abuse-Deterrent, Microsphere-in-Capsule Formulation of Extended-Release Oxycodone: Alternative Modes of Administration to Facilitate Pain Management in Patients with Dysphagia,” in the journal Current Medical Research and Opinion.
The data comes from multiple in vitro and pharmacokinetics studies that show Xtampza ER (oxycodone extended-release) can be given by sprinkling capsule contents onto soft food, through enteral tubes (nasogastric [NG] and gastrostomy), or by crushing/chewing without affecting the drug's release profile of the formulation. Researchers had reviewed Xtampza ER data from in vitro and in vivo studies conducted to demonstrate support for alternate routes and modes of administration.
They found no difference in the dissolution profile of Xtampza ER given with various soft foods or when mixed in various liquid vehicles and given via NG or gastrostomy tubes. Its microspheres were bioequivalent to intact Xtampza ER capsules when sprinkled onto applesauce and given orally. Also, it maintained its pharmacokinetic profile as no bolus dose of opioid was released.
Lead study author, Dr. Bill McCarberg added, "Xtampza ER could provide a valuable treatment option, especially in those patients who have dysphagia or an aversion to swallowing tablet formulations and for whom alternative therapies are not a viable therapeutic option.”
Xtampza ER, an opioid agonist, was granted approval by the Food and Drug Administration (FDA) in April 2016 for the management of pain severe enough to require daily, around-the-clock, long-term opioid treatment and for which alternative treatment options are inadequate. It is available as 9mg, 13.5mg, 18mg, 27mg, and 36mg strength extended-release capsules.
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