Xtampza ER Approved
April 26, 2016 – The U.S. Food and Drug Administration (FDA) approved Xtampza™ ER (oxycodone) extended-release capsules manufactured by Collegium Pharmaceuticals. Xtampza ER is a C-II opioid indicated for use as twice-daily treatment of chronic, severe pain that needs constant opioid therapy and that has not been controlled by other treatment. Xtampza ER will launch as 10mg, 15mg, 20mg, 30mg and 40mg capsules. The opioid uses a new method to significantly reduce both the potential for abuse and the risk of overdosing. This new method mixes wax and fatty acids to form microspheres, each that eachs contain active drug ingredients. The wax keeps the opioid from being dissolved and injected, and it also prevents rapid release of the oxycodone if the capsules are mashed. Additionally, capsules can be opened to sprinkle on soft foods and then given to patients who cannot swallow whole capsules.
Adverse reactions or quality problems experienced with the use of a recalled product may be reported to the FDA’s MedWatch Adverse Event Reporting Program either online, by regular mail or by fax.
- Complete and submit the report Online: www.fda.gov/medwatch/report.htm
- Regular Mail or Fax: Download form www.fda.gov/MedWatch/getforms.htm or call 1-800-332-1088 to request a reporting form, then complete and return to the address on the pre-addressed form, or submit by fax to 1-800-FDA-0178
Actual drug patent expiration dates and a availability of new medications are subject to change due to patent litigation, settlement agreements, additional patents, exclusivities, and final FDA approval. Distribution and availability of new medications at pharmacies may not occur immediately following FDA approval. Patients are advised to speak with their healthcare professional or pharmacist regarding appropriateness as well as actual availability.
*This is provided for information only. The reference to any medication above does not mean the medication is covered by your plan.