A new generic version of Buprenorphine, known in the rehab world as Suboxone, is now being produced by Mylan N.V and Dr. Reddy’s Laboratories thanks to an FDA approval. Suboxone combines buprenorphine and naloxone as a daily medication paired with addiction behavioral therapy.
Brand name Suboxone costs about $200 a month without insurance, a price that can be hard to afford for someone struggling with addiction or recently released from treatment without an income. The decision to approve the generic version was aimed to make treatment more available for more people. This is the one of the first ways the Trump administration has followed through with one of the 5-point strategies announced earlier this year to tackle the opioid crisis.
“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,” FDA Commissioner Scott Gottlieb, MD, said in a statement.
“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. Patients addicted to opioids who are eventually treated for that addiction and successfully transition onto medicines like buprenorphine aren’t swapping 1 addiction for another, as is sometimes unfortunately said. They’re able to regain control of their lives and end all of the destructive outcomes that come with being addicted to opioids. When coupled with other social, medical, and psychological services, medication-assisted treatments are often the most effective approach for opioid dependence.”
The generic version will be similar to the name brand name, to be taken sublingually and in various forms of strengths. Same as Suboxone, the generic version may only be prescribed by drug addiction certified prescribers in conjunction with counseling and behavioral therapy sessions. Side effects include fluid causing swelling in lower limbs, burning mouth, constipation, excessive sweating, headache, inflammation of oral mucous membrane, insomnia, nausea, oral numbness, pain, signs and symptoms of withdrawal, and vomiting.
Source : The Recover Newsroom