Buprenorphine Injection, a Medication-Assisted Treatment

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The first injectable buprenorphine product has been approved by the U.S. Food and Drug Administration (FDA) for treating moderate-to-severe opioid use disorder (OUD) in patients in whom treatment with a product containing transmucosal buprenorphine has been initiated for approximately 7 days. OUD is the diagnostic term utilized for a chronic neurobiological disease characterized by a challenging array of opioid use resulting in considerable distress or impairment.

This involves signs and symptoms reflecting incontrollable, lengthy self-determination of opioid substances for no genuine medical cause or, in the presence of another medical condition necessitating treatment with opioid, and the utilization of opioid in doses over the required amount for treating the medical condition. At present, for treating OUD, buprenorphine is only approved for administration in the form of an oral film or tablet, or as an implant. Buprenorphine is a great choice for medication-assisted treatments (MAT) to deal with the issue of opioid overdose crisis that has resulted in the death of nearly 50,000 individuals in 2016. A combination of medication with behavioral and counseling therapy is included in MAT for treating opioid abuse, clinically referred to as OUD.

A new option is provided for treatment by Sublocade for patients undergoing recovery and having the possibility of being benefitted by once-monthly injection in comparison to other forms of buprenorphine, like decreasing the burden of medication administration in accordance with the prescription. Sublocade’s approval was supported by an independent advisory committee of FDA held on October 2017. The continuing work of FDA is to emphasize on facilitating access to recovery services, treatment, and prevention, including the complete variety of MAT, for decreasing the scope of opioid crisis.

It is also an important consideration of the “Five-Point Strategy to Combat the Opioid Crisis” of the U.S. Department of Health and Human Services. There is some cynic among the doctors that a buprenorphine injection will be demanded by several patients if there is no fear of the criminal justice system. Buprenorphine strips that dissolve under the tongue are liked by people. Yet, doctors like to have a choice for patients having problem in buprenorphine administration, or those who are suscpet4ed of selling their strips.

The administration of Sublocade is in the form of an injection by a healthcare professional. It results in the formation of a firm reservoir. Following the formation of the reservoir, there is gradual release of buprenorphine over the period of a month. Two clinical trials assessed the drug-device product in 848 adults with moderate-to-severe addition of opioid. Treatment with the buprenorphine-naloxone film was initiated in all participants. Following the stability of buprenorphine dose, Sublocade was administered to patients. Opioid use self-reports and results of positive urine tests in comparison to the placebo group came in Sublocade treated patients after several weeks. Post-market studies were considered crucial by the FDA for identifying the patients on whom a higher dose regimen would be beneficial and for evaluating the safety of Sublocade in patients without prior administration of sublingual buprenorphine.

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