On Thursday, the U.S. Food and Drug Administration approved the first generic versions of Suboxone, a medication that combines buprenorphine and naloxone. Suboxone is a sublingual film, which means it is applied under the tongue. Used daily, Suboxone is effective in treating cravings for opioids and the high they produce, along with withdrawal symptoms, according to the FDA. The medication is used together with behavioral therapy and counseling.
The comprehensive approach that combines behavioral therapy, counseling, and medication-assisted treatment to combat opioid use disorder (OUD) is known as (MAT). The Substance Abuse and Mental Health Services Administration, reports that patients that receive MAT for treatment of OUD slice their risk of death from every cause in half.
Improving access to prevention, treatment, and recovery services, including the full range of MAT, is a focus of the Food and Drug Administration’s continued effort to “reduce the scope of the opioid crisis.” It is also one part of the Department of Health and Human Services’s Five-Point Strategy to help fight the opioid crisis.
FDA Commissioner Scott Gottlieb, M.D., said the following about the recent developments.
“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. That includes promoting the development of better drugs, and also facilitating market entry of generic versions of approved drugs to help ensure broader access,” “The FDA is also 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.”
The generic version of Suboxone will be sold by partners, Dr. Reddy’s Laboratories SA and Mylan N.V., according to the the New York Times. The partners haven’t responded about when the generic medication will be available, or how much the costs will be. However, in most cases, the difference between generic medication and brand name medications is mainly price, with generic meds often being significantly less expensive. In fact, generic medicines are typically 80 to 85 percent less than their brand-name counterparts.
The @US_FDA has approved the first #generic version of under-tongue #addiction film #Suboxone, part of effort to make #opioid treatment accessible to more people. https://t.co/8eWOuvXDE9 pic.twitter.com/Qr0lgSvBXi
— Linda A. Johnson (@LindaJ_onPharma) June 14, 2018
If, indeed, the generic form of Suboxone has a less expensive price tag, it will be a breath of fresh air since the United States is in the midst of a crushing opioid epidemic. Lower drug prices will mean many Americans can afford much-needed medications, and any boost to combating the opioid crisis could turn out to be a monumental win.