FDA Approves Once-Monthly Injection for Opioid Addiction
FRIDAY, Dec. 1, 2017 -- Sublocade, a once-monthly injection of buprenorphine to treat opioid use disorder, has been approved by the U.S. Food and Drug Administration.
Buprenorphine has been shown to reduce opioid withdrawal symptoms and the desire to use opioids, "without causing the cycle of highs and lows associated with opioid misuse or abuse," the FDA said.
Sublocade was evaluated in clinical studies involving 848 adults who were diagnosed with moderate-to-severe cases of opioid use disorder. The most common side effects included constipation, nausea, vomiting, headache, drowsiness, and injection-site pain. Sublocade's safety and effectiveness were not evaluated in individuals under age 17, the FDA said.
The maker of Sublocade -- Indivior -- is required to conduct additional studies to see if some patients could benefit from a dose of Sublocade that's higher than currently approved.
Indivior is based in the United Kingdom.
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Posted: December 2017