Patients struggling to break dependence on opioids will soon have a cheaper treatment option available following the US Food and Drug Administration’s (FDA) decision to approve the first generic sublingual version of Suboxone (buprenorphine and naloxone).
In April 2017, the US Department of Health and Human Services (HHS) unveiled a five-point Opioid Strategy to tackle the growing problem of opioid addiction in the United States. One of the key priorities identified in the document was the importance of improving access to prevention, treatment and recovery support services.
Commenting on the FDA’s approval of generic sublingual Suboxone, the agency’s commissioner Scott Gottlieb, MD, reiterated the agency’s dedication to advancing better opioid use disorder treatments and improving availability of these medications, which “includes promoting the development of better drugs, and also facilitating market entry of generic versions of approved drugs to help ensure broader access”.
He emphasized the important role of medication-assisted treatment (MAT) when used alongside counseling and behavioral therapies as a treatment for opioid dependence. “When coupled with other social, medical and psychological services, MATs are often the most effective approach for opioid dependence,” he asserted.
Suboxone’s active ingredient buprenorphine is used in MAT to minimize opioid withdrawal symptoms and reduce the desire to use opioids. Naloxone, the other active ingredient, blocks the effects of opioids, including the analgesic effect and feelings of well-being that can lead to addiction and abuse of narcotics. The drugs may only be prescribed by prescribers certified by the Drug Addiction Treatment Act.
Approval for a generic version of the drug to be used as part of a complete treatment plan also involving counseling and psychosocial support was granted to Mylan Technologies and Dr. Reddy’s Laboratories. To gain FDA approval, generic drugs need to be the same quality and achieve the same manufacturing and packaging quality standards as their branded counterparts.
Measures to address the national opioid addiction crisis “on all fronts” are being formulated and actioned by the FDA, in particular, decreasing exposure to opioids and taking prophylactic measures to prevent new addiction. It is also encouraging “more appropriate prescribing” and working to improve the treatment and support given to those with opioid use disorder.
“The FDA is… taking new steps to address the unfortunate stigma that’s sometimes associated with the use of opioid replacement therapy as a means to successfully treat addiction,” said Gottlieb, adding that patients treated for addiction who transition to medication such as buprenorphine are not simply switching their addiction to a different drug. Instead, he said this form of treatment helps patients regain control over their lives and avoid the “destructive outcomes” often associated with opioid addiction.
More than 11 million people misused prescription opioids in the United States in 2016, according to figures from the Substance Abuse and Mental Health Services Administration’s 2016 National Survey on Drug Use and Health. The report found around 2.1 million people had misused prescription opioids for the first time during this period.
