Abuse Resistant Form for Zohydro ER Approved
The U.S. FDA approved a new formulation for all strengths of Zohydro ER, the single-agent, extended-release hydrocodone product, which is a schedule II controlled substance. Zohydro ER, manufactured by Zogenix, is indicated to treat severe chronic pain that needs continuous treatment and that has not been relieved by previous therapy options.
The new form is considered ‘abuse resistant’ and it is made with a proprietary technology called BeadTek. BeadTek creates thick, sticky goo if the capsules are opened or crushed and the contents dissolved in liquids or solvents. The FDA has not yet approved product labeling that specifies abuse resistance, however, Zogenix, is planning to provide the FDA with results of studies showing that the new formulation is difficult to abuse.
The first FDA approved version of Zohydro ER was approved in October 2013 without any abuse deterrents and will be phased out and replaced with the new form during the second quarter of 2015.
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.