Federal health regulators on Thursday gave their approval to the first injectable form of a leading medication used to treat patients who are recovering from addiction to prescription painkillers, heroins, and other opioids.
FDA Approves Use Of Injectable Sublocade For Opioid Use Disorder
The U.S. Food and Drug Administration greenlighted the monthly injection of Sublocade for adults suffering from opioid use disorder who are already stabilized on addiction medication.
The treatment can potentially reduce relapses that may happen when patients stop taking currently available daily medication. Studies, however, have not shown this benefit and the treatment comes with a prohibitive price of $1,580 per monthly dose. In comparison, Suboxone, the older version of the drug, only costs $100 a month.
Opioid Epidemic In The United States
The injectables approval comes as the United States grapples against the deadliest drug epidemic in the nation's history marked by gaps in medication-based treatment for individuals recovering from their addiction to opioids.
Opioids, which include illegal narcotics such as heroin and fentanyl, and painkillers like Oxycontin can dampen the immune system of the body. It can negatively affect the body's infection-fighting immune cells and antibody response. Its sedative effect cake makes a person breathe slower, and shallowly, which can cause potentially-fatal breathing problems.
Last year, most of the 64,000 cases of drug overdose in the United States involve opioids. Doctors now reduce opioid prescriptions to prevent addiction but deaths due to overdose remain high.
"Given the scale of the opioid crisis, with millions of Americans already affected, the FDA is committed to expanding access to treatments that can help people pursue lives of sobriety," said FDA Commissioner Scott Gottlieb. "As part of our ongoing work in supporting the treatment of those suffering from addiction to opioids, the FDA plans to issue guidance to expedite the development of new addiction treatment options. "
Sublocade Side Effects
Based on clinical studies that tested the safety and efficacy of the drug, common side effects of Sublocade include nausea, constipation, headache, vomiting, drowsiness, itching, and pain at the injection site, and abnormal liver function test.
Sublocade will be part of a complete treatment program, which involves counseling and psychosocial support.
"In a Phase 3 clinical study, SUBLOCADE helped patients refrain from illicit opioids for more weeks compared to placebo," said Brent Boyett, SUBLOCADE clinical investigator. "Used in combination with counseling and psychosocial support, SUBLOCADE is a transformational new drug that offers a treatment option for people with moderate to severe opioid use disorder."
