Generic Suboxone Approved by FDA

FDA Approves First Versions of Generic Suboxone

The U.S. Food and Drug Administration (FDA) published a press release approving generic versions of the brand-name medication Suboxone. This is big news for those of us struggling with opioid addiction. Oftentimes, pharmaceutical companies with brand-name prescriptions can dominate a specific market, leading to extremely high costs and lack of access to these life-saving treatment options. The FDA made this decision to provide this highly successful form of medication-assisted treatment (MAT) to those who are in need on a larger scale and across socioeconomic lines in efforts to combat the opioid epidemic affecting every demographic of our nation.

The FDA has worked hard to research and approve different methods of MAT in recent decades in hopes of preventing the many negative side effects of addiction such as crime, self-harm, and accidental fatalities. We know just how deadly addiction to opiates can be as we’ve watched the national overdose death rate skyrocket from fifteen years prior and continue to steadily grow each year since. Studies conducted by the Substance Abuse and Mental Health Services Administration (SAMHSA) have found that patients involved in MAT programs for their opioid use disorder halve their risk of death. MAT incorporates the administration of FDA-approved medications such as buprenorphine (Suboxone or Subutex), naltrexone (Vivitrol), or methadone coupled with behavioral therapy and individual counseling with the goal of reducing withdrawal symptoms, decreasing the appeal of illicit opioid use, and changing cognition and behaviors in the patient to ensure long-term success.

Due to the positive outcomes for patients receiving MAT, we can utilize these types of treatment options to fight the opioid crisis everywhere, not just in affluent areas where patients have top-notch health insurance to cover most, if not all, of the cost of brand-name medications. Commissioner of the FDA, Scott Gottlieb, M.D. stated, “The FDA is taking new steps to advance the development of improved treatments for opioid use disorder, and to make sure these medicines are accessible to the patients who need them.” Up until this press release last week, Suboxone was the only form of the medications buprenorphine and naloxone available in a sublingual film which is applied under the tongue, dissolving quickly and with ease. Gottlieb went on to say, “[Accessibility] includes promoting the development of better drugs, and also facilitating market entry of generic versions of approved drugs to help ensure broader access.”

In 2017, the FDA created their Drug Competition Action Plan in order to increase competition in the prescription drug market which decreases prices for the consumer. The plan includes new policy to expedite the process of getting generic medications reviewed and put on the market to provide affordable alternatives to many expensive prescriptions. Gottlieb stated in the press release for this plan that, “No patient should be priced out of the medicines they need, and as an agency dedicated to promoting public health, we must do our part to help patients get access to the treatment they require.”

These generic drugs will be quality-assured to meet the same standards as their brand-name counterparts – from the medication itself to the packaging sites, every aspect will be inspected and regulated by the FDA. Currently, two companies have been approved to market their generic buprenorphine and naloxone sublingual film strips: Mylan Technologies Inc. and Dr. Reddy’s Laboratories SA. Rolling out these affordable medications should bring about a change in who can receive successful treatment for opioid addiction and prevent many overdose deaths. If you or a loved one are continuously struggling with addiction to opiates, reach out for help and seek the treatment you deserve today.