Opioid addiction has become a deadly crisis that is spreading through America. We have come a long way in trying to find ways to overcome opioid drug overdoses, in which 80 Americans die each day. The FDA approved the first implantable opioid addiction drug, Probuphine, with a 12-5 in favor vote in January. It is one of only a handful of medications approved for the treatment of opioid dependency.
The implantable drug will dispense a low dose of anti-addiction medication over a six-month period. The drug is intended for patients who have already shown they are stable on low doses of buprenorphine. Previous treatments were only available in a dissolvable film and tablet. The FDA is hoping to reduce the chances of the drug being consumed by children or resold and abused.
Those who voted against the approval are concerned the committee was approving the drug out of desperation to have more treatment options available. They also expressed concerns about the science used to prove the implant was safe and the training of doctors would need to implant the drug. In a statement made by the FDA commissioner, Robert M. Califf said: “Opioid abuse and addiction have taken a devastating toll on American families. We must do everything we can to make new, innovative treatment options available that can help patients regain control over their lives.”
Braeburn Pharmaceuticals is the manufacturer for the implant. Behshad Sheldon, president and CEO, said in a statement: “Opioid addiction is a chronic disease and should be treated the same way we treat other serious, chronic diseases – with evidence-based medicine.” As of now, Braeburn has been campaigning lawmakers to make an exception to the cap for the Probuphine tablet, which addiction specialists can only prescribe to 100 patients.
Sheldon said previously that if the drug was approved that Braeburn would hold 253 sessions to train 3,000 doctors in the first six weeks of approval to surgically insert and remove the implants. The wholesale cost is $825, but they are still unsure what the implant will cost doctors and patients.
I think that America will always have on going issues with opioid addiction, but however doctors, Pharmaceutical companies and the FDA can help stop the epidemic from being an evener bigger crisis is welcome.