FDA Approves New Low Dose Option for Opioid Dependence

The FDA has approved Zubsolv (buprenorphine/naloxone CIII sublingual tablets) 0.7mg/0.18mg for the treatment of patients with opioid dependence.

This expands the doses available for Zubsolv to six different dosages (11.4mg/2.9mg, 8.6mg/2.1mg, 5.7mg/1.4mg, 2.9mg/0.71mg, 1.4mg/0.36mg & 0.7mg/0.18mg). The drug was originally approved in 2013.

Adverse events commonly reported with the use of Zubsolv include headache, nausea, vomiting, hyperhidrosis, constipation, signs and symptoms of withdrawal, insomnia, pain, and peripheral edema.

—Michael Potts

Reference:

Orexo. U.S. FDA Approves Orexo's low dose Zubsolv® buprenorphine and naloxone sublingual tablets (CIII) [press release]. October 6, 2016. http://www.prnewswire.com/news-releases/us-fda-approves-orexos-low-dose-zubsolv-buprenorphine-and-naloxone-sublingual-tablets-ciii-300340469.html.