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| FDA approves anti-addiction implant to prevent opioid dependence | FDA approves anti-addiction implant to prevent opioid dependence |
| (35 minutes later) | |
| The US Food and Drug Administration approved the first implantable opioid addiction treatment on Thursday. | The US Food and Drug Administration approved the first implantable opioid addiction treatment on Thursday. |
| This decision comes as the Obama administration works to respond to America’s opioid addiction epidemic – where 80 Americans die each day from overdoses. | This decision comes as the Obama administration works to respond to America’s opioid addiction epidemic – where 80 Americans die each day from overdoses. |
| Related: A deadly crisis: mapping the spread of America's drug overdose epidemic | Related: A deadly crisis: mapping the spread of America's drug overdose epidemic |
| “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,” said FDA commissioner, Robert M Califf, in a statement. | “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,” said FDA commissioner, Robert M Califf, in a statement. |
| The implant, Probuphine, continuously dispenses a low dose of anti-addiction drug buprenorphine over a six-month period. It is intended for patients who have already shown they are stable on low doses of buprenorphine, a common treatment for opioid addiction that was previously only available as a dissolvable film and tablet. | The implant, Probuphine, continuously dispenses a low dose of anti-addiction drug buprenorphine over a six-month period. It is intended for patients who have already shown they are stable on low doses of buprenorphine, a common treatment for opioid addiction that was previously only available as a dissolvable film and tablet. |
| It is one of a handful of medications approved for the treatment of opioid dependence. The other two are methadone and naltrexone, the latter which is combined with buprenorphine for some opioid addiction drugs. | It is one of a handful of medications approved for the treatment of opioid dependence. The other two are methadone and naltrexone, the latter which is combined with buprenorphine for some opioid addiction drugs. |
| An FDA advisory committee voted 12-5 in favor of approving the implant in January. | An FDA advisory committee voted 12-5 in favor of approving the implant in January. |
| Proponents of the implant hoped it would reduce the chances of the drug being consumed by children or resold and abused. | Proponents of the implant hoped it would reduce the chances of the drug being consumed by children or resold and abused. |
| Those who voted against the drug’s approval expressed concerns about the science used to prove the implant was safe and the training doctors would need to implant the drug. Some also said they were concerned the committee was approving the drug out of the desperation to have more treatment options to address the crisis. | Those who voted against the drug’s approval expressed concerns about the science used to prove the implant was safe and the training doctors would need to implant the drug. Some also said they were concerned the committee was approving the drug out of the desperation to have more treatment options to address the crisis. |
| Related: FDA to announce whether it will approve implant for opioid addicts | Related: FDA to announce whether it will approve implant for opioid addicts |
| The drug is manufactured by Braeburn Pharmaceuticals, whose president and CEO, Behshad Sheldon, said in a statement that the company hopes this is the first of what they hope to be many new treatments for addiction. “Opioid addiction is a chronic disease and should be treated the same way we treat other serious, chronic diseases – with evidence-based medicine,” Sheldon said. | |
| The wholesale cost for Probuphine is $825 per month, but it is not yet clear how much the implant will cost doctors and patients. | |
| Buprenorphine was approved as a tablet in 2002. Addiction specialists have called on increased access to the drug, which specially-trained doctors can only prescribe to 100 patients. Sheldon told the Guardian this week that Braeburn has been campaigning lawmakers to make Probuphine an exception to this cap. | Buprenorphine was approved as a tablet in 2002. Addiction specialists have called on increased access to the drug, which specially-trained doctors can only prescribe to 100 patients. Sheldon told the Guardian this week that Braeburn has been campaigning lawmakers to make Probuphine an exception to this cap. |
| Doctors who prescribe the medication must be trained in how to surgically insert and remove the four one-inch-long set of rods. Sheldon said previously that if the drug was approved, Braeburn would hold 253 sessions to train 3,000 doctors in the first six weeks of its approval. | Doctors who prescribe the medication must be trained in how to surgically insert and remove the four one-inch-long set of rods. Sheldon said previously that if the drug was approved, Braeburn would hold 253 sessions to train 3,000 doctors in the first six weeks of its approval. |