The FDA has approved Collegium Pharmaceutical Inc's oxycodone extended-release capsules (Xtampza ER) for severe pain.
The FDA has approved Collegium Pharmaceutical Inc’s oxycodone extended-release capsules (Xtampza ER) for severe pain.
The capsules are designed to be taken twice daily by patients who need around-the-clock long-term opioid treatment and for patients with no other viable treatment options.
Xtampza ER uses the company’s DETERx technology to maintain its drug release profile, even if the capsule is chewed or crushed prior to administration.
For those who need to sprinkle the capsule contents onto soft foods or through a gastrostomy or nasogastric feeding tube, Collegium lists instructions on its label.
“The FDA approval of Xtampza ER is a major milestone for Collegium,” Michael Heffernan, CEO of Collegium, said in a press release. “Our DETERx technology platform was developed internally, and our lead product completed an extensive battery of abuse-deterrent testing consistent with the FDA Guidance on Abuse-Deterrent Opioids. Collegium is committed to supporting responsible, appropriate prescribing for only those patients suffering from chronic pain who don’t have alternative nonopioid treatment options. Xtampza ER will provide clinicians with another treatment option for these patients.”
Collegium will launch Xtampza ER in the United States before the end of 2016. It will come in 5 dose strengths: 10 mg, 15 mg, 20 mg, 30 mg, and 40 mg.
The most common adverse effects associated with the drug are nausea, headache, and constipation.