Abuse-Deterrent Troxyca ER Approved
August 19, 2016 – The FDA approved Troxyca ER (naltrexone/oxycodone) which is a CII opioid agonist/opioid antagonist combination indicated for continual maintenance treatment of severe pain that has not been successfully managed with other treatment options. Troxyca ER, manufactured by Pfizer, is an abuse-deterrent formulation in which the combination of naltrexone and oxycodone cancels out the euphoric effects of the opioid when the mediation is crushed and mixed together.
Troxyca ER carries the boxed warning even though it is an extended release, abuse deterrent medication. Taking Troxyca ER may be associated with abuse, addiction, misuse, overdose and death. Babies born to women who use it during pregnancy may suffer neonatal withdrawal syndrome and older children may overdose if taken accidentally. Troxyca ER will be marketed in six strengths and it is taken at 12-hour intervals. Healthcare providers experienced in prescribing opioids to control chronic pain should prescribe the lowest effective dose of Troxyca ER. Doses above 80mg/9.6mg should be reserved for patients who have developed tolerance to high doses of other opioids.
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 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.