The Food and Drug Administration (FDA) has approved the first once-monthly injection to treat opioid use disorder (OUD) in the latest effort to tackle the nation’s opioid epidemic.
Sublocade is an injection of buprenorphine for adults with moderate-to-severe OUD who have initiated treatment with a transmucosal buprenorphine-containing product and have been on a stable dose of buprenorphine treatment for a minimum of seven days. Buprenophine as an OUD treatment is currently administered as either a tablet, implant or a film that dissolves in the mouth. Sublocade offers another treatment option to patients, and one that reduces the burden of taking a daily medication.
Sublocade is a drug-device combination product utilizing the Atrigel Delivery System in a pre-filled syringe. It is injected by a health care professional under the skin of the patient as a solution and forms a solid deposit containing buprenorphine. After initial formation of the deposit, buprenorphine is released by the breakdown of the deposit.
“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, M.D. “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.”
The FDA announced earlier this year that it would step up its efforts to fight the country’s epidemic as part of the U.S. Department of Health and Human Services’ Five-Point Strategy to Combat the Opioid Crisis. One of those actions was to provide a full range of medication-assisted treatments for opioid use disorder. Medication assisted treatments (MAT) combines approved medications (currently, methadone, buprenorphine or altrexone) with counseling and other behavioral therapies to treat patients with OUD.
Regular adherence to MAT with buprenorphine reduces opioid withdrawal symptoms and the desire to use opioids, without causing the cycle of highs and lows associated with opioid misuse or abuse, the agency said in a news release. At proper doses, buprenorphine also decreases the pleasurable effects of other opioids making continued opioid abuse less attractive.
Patients receiving MAT for the OUD cut their risk of death from all causes in half, according to the Substance Abuse and Mental Health Services Administration.
Source: FDA News Release