FDA Approves First Generic Versions of Suboxone® for Opioid Addiction Treatment

In a move that many are speculating will increase access to quality opioid addiction treatment, the Food and Drug Administration (FDA) has approved the first generic form of sublingual (under-the-tongue) buprenorphine with naloxone, commonly known as Suboxone®. Buprenorphine with naloxone is a staple of medication-assisted treatment (MAT) for opioid addiction and has helped scores of opioid use disorder sufferers diminish their cravings, ease their withdrawal symptoms and find their way to long-term abstinence. Until very recently, the drug was sold under three specific brand names (Suboxone, Zubsolv®, and Bunavail®); however, the FDA is rolling out generic versions as part of a larger comprehensive initiative to combat opioid abuse.

Five-Point Opioid Addiction Treatment Plan

In the wake of consistently escalating opioid addiction fatalities, the FDA has unveiled a five-point plan for prevention and treatment. Elements of the plan include better addiction prevention, treatment, and recovery services; better data; better pain management resources; better targeting of overdose-reversing drugs; and better research. The fourth step includes continued and expedited approval of generic drugs that make MAT more affordable and accessible. The agency seeks to promote marketplace competition and help reduce prices to improve access to these potentially life-saving medications. Generic drugs approved by the FDA have, among other things, the same quality as brand-name drugs. Generic drug manufacturing and packaging sites must meet the same quality standards as those of brand-name drugs.

Guidelines for Treatment

The treatment protocol for opioid addiction treatment with buprenorphine is still the same. Patients must have approval from a licensed and credentialed medical professional in order to take the drug. Regimens should be closely monitored by patients’ healthcare provider, and these medications are not a substitution for other elements of treatment like counseling and supplemental behavioral therapy. Stakeholders are optimistic that this is the first of many moves toward making MAT easier for patients who have faced administrative and cost-related barriers in the past. Mylan Technologies Inc. and Dr. Reddy’s Laboratories SA received approval to market buprenorphine and naloxone sublingual film in multiple strengths.