FDA’s Advisory Committee backs use of Collegium Pharmaceutical’s Xtampza ER
A US Food and Drug Administration (FDA) advisory committee is in favor of approval of a new extended-release, abuse-deterrent Oxycodone. The committee has voted 23 to 0 to support the approval of Collegium Pharmaceutical's Xtampza ER.
The members of the Anesthetic and Analgesic Drug Products Advisory Committee and the Drug Safety and Risk Management Advisory Committee said that the drug will offer an alternative for a number of people living with chronic pain having trouble swallowing.
It has also been found that Xtampza ER does not get sticky when it gets wet like the abuse-deterrent form of OxyContin, Purdue. Also, the new drug does not transform into an immediate-release form. Collegium has shared that the medicine can also be given by breaking open the capsule and pouring the oxycodone microspheres into a feeding tube or sprinkle over soft food or can directly put into mouth.
Panelist Brian Bateman from Harvard Medical School said that the company has proven the formulation would not prevent abuse by inhalation or injection. "We've seen data suggesting the prevalence of dysphagia is substantial in chronic pain patients. This will meet that clinical need", affirmed Bateman.
Panelist Raeford Brown, a professor of anesthesiology and pediatrics at the University of Kentucky College of Medicine, has termed the medication to be a true advance in the issue of deterrence of opioid abuse.
If the drug gets approved then Xtampza ER will join four other approved abuse-deterrent ER Opioids.