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FDA approves low-dose tablet of Zubsolv for opioid dependence
The FDA today approved a low-dose sublingual tablet of Zubsolv for treatment of opioid dependence, according to a press release from Orexo AB.
“The approval of the 0.7mg Zubsolv is another significant milestone for Orexo because it marks the completion of our pharmaceutical development plan for Zubsolv,” Nikolaj Sørensen, MSc, CEO and president of Orexo AB, said in the release. “The new dosage has been developed in response to physician requests to be able to tailor dosing as they taper patients and ultimately provide a lower minimally effective maintenance dose.”
Zubsolv (buprenorphine/naloxone, Orexo AB), which contains 0.7 mg of buprenorphine and 0.18 mg of naloxone, will be available in U.S. pharmacies in early 2017, according to the release.
The 0.7 mg dose of Zubsolv is approximately 50% lower than any other buprenorphine/naloxone product approved in the U.S.
Zubsolv has the highest level of child-resistant, unit dose, F1 packaging designed to reduce risk of unintended pediatric exposure.