The U.S. Food and Drug Administration's advisory committee supports new drugs that could treat opioid addictions. This comes less than a week after President Donald Trump declared the opioid epidemic a public health emergency.
The FDA's Psychopharmacologic Drugs Advisory Committee and Drug Safety and Risk Management Advisory Committee voted 18-1 on Tuesday that Indivior's injectable drug, known as RBP-6000, could benefit patients addicted to opioids.
If approved, the product would be the first monthly injectable buprenorphine treatment.
Board-certified addiction specialist Dr. Amit Vijapura was there when the FDA's advisory committee ruled that Indivior's new medication could help patients.
“It’s just a tiny needle that goes under the skin and delivers the medicine and patients get medicine for thirty days,” Vijapura said.
This drug, RBP-6000, contains buprenorphine medication used to treat addiction. It includes a sustained-release formulation using the ATRIGEL delivery system, which consists of a polymeric solution of biodegradable content.
Right now, Vijapura said recovering addicts are taking daily tablets or putting a film under their tongue. He said patients can abuse or divert this type of prescription.
If approved, this injection would eliminate patients being responsible for their consistent doses.
“We inject the needle underneath the skin; 2 millimeters underneath the skin. Then, we deliver the medicine and we take out the needle, we wipe it, and the procedure is done,” Vijapura said.
Vijapura said it takes 30 seconds to administer this drug. Physicians will use a syringe and they will inject it in your abdomen, shoulder or backside area.
“Having an injectable for the medication provides safety and security for patients who are getting the medicine,” Vijapura said.
The FDA is expected to make its decision about Indivior’s injectable drug by Nov. 30. Typically, the FDA follows the recommendation of its advisory panels.
On Wednesday, the FDA advisory committee met to review another medication with a similar concept, but a different type of technology and compound. The FDA's Psychopharmacologic Drugs Advisory Committee and the Drug Safety and Risk Management Advisory Committee jointly voted 17-3 that Braeburn's injectable drug, known as CAM2038, could be effective in treating patients who are addicted to opioids.