Sublocade, a once-monthly injection of buprenorphine to treat opioid use disorder, has been approved by the U.S. Food and Drug Administration.
Opioid abuse is diagnosed when a person's pattern of opioid use leads to "significant impairment or distress and includes signs and symptoms that reflect compulsive, prolonged self-administration of opioid substances for no legitimate medical purpose," or opioids are taken in far higher-than-recommended doses, the agency said in a news release.
The drug 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.
"Everyone who seeks treatment for opioid use disorder deserves the opportunity to be offered the treatment best suited to the needs of each individual patient, in combination with counseling and psychosocial support, as part of a comprehensive recovery plan," FDA Commissioner Dr. Scott Gottlieb said.
Sublocade was evaluated in clinical studies involving nearly 850 adults who were diagnosed with moderate-to-severe cases of the 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 people under age 17, the FDA said.
Maker Indivior Inc. is required to conduct additional studies to see if some people could benefit from a dose of Sublocade that's higher than currently approved, the agency said.
Indivior is based in the United Kingdom.
Visit the FDA to learn more.
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