New Strength for Zubsolv
October 4, 2016 - The U.S. FDA approved a new low strength of Zubsolv® (buprenorphine 0.7mg/naloxone 0.18mg) sublingual tablets, manufactured by Orexo. Zubsolv is a CIII controlled substance that is used to treat adults with opioid dependence disorder, along with counseling and psychosocial support. Zubsolv had already been approved by the FDA in five higher strengths for both of its components. According to Orexo, the range of available strengths will enable prescribers to better tailor each patient’s therapy to individual needs. After patients show signs of opioid withdrawal, Zubsolv is given as several doses on the first day, and then decreased to once a day. A Medication Guide and product labeling warn that one component, buprenorphine, is an opioid that can be abused. As with all opioids, it also can cause potentially severe breathing problems and it can be life-threatening if swallowed by children. The other component, naloxone, has very little activity when taken sublingually, but it blocks the euphoric effects of buprenorphine if the tablets are crushed, dissolved or injected. Patients taking Zubsolv should be supervised by a healthcare professional and refills for prescriptions should be limited to a few days at a time, at least until an effective dose is determined. Orexo plans on launching the new strength early next year.
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.