FDA Approves Buprenorphine to Treat Opioid Dependence

On May 26, 2016, FDA approved Probuphine, a buprenorphine implant for the treatment of opioid dependence. Probuphine is the first buprenorphine implant to be approved in the United States. Buprenorphine was previously approved by FDA in the form of a pill, or film, for the treatment of opioid dependence, FDA wrote in a press statement.

Probuphine is marketed by Titan Pharmaceuticals and Braeburn Pharmaceuticals and consists of four one-inch rods that are implanted under the skin on the inside of the upper arm and deliver a consistent low dose of buprenorphine for six months. According to FDA, the rods must be surgically inserted by a medical professional that has completed the Probuphine Risk Evaluation and Mitigation Strategy (REMS) program. FDA is requiring additional postmarketing studies of the drug to determine the safety and feasibility of placing Probuphine implants for additional courses of treatment, the agency said in a press announcement.

In January 2016, the Psychoparmacologic Drug Advisory Committee

of Probuphine as a maintenance treatment for opioid dependence. Although the committee recommended approval, it also raised concerns about the safety of the drug, saying in a report, “the product presents novel safety concern among products used to treat opioid dependence associated with the surgical insertion and subsequent need for removal of the implant rods.”

The committee compared the drug to Norplant, a progesterone release implant contraceptive, no longer marketed in the US as a result of “insertion and removal-related complications, some of them with disabling consequences.” FDA has required a boxed warning on Probuphine, alerting patients of potential side effects including implant migration, protrusion, expulsion, and nerve damage.

In the past, FDA has addressed growing concerns about the increase in opioid dependence in the US. The agency lists supporting better treatments as a priority on its Opioid Action Plan, including increasing access to naloxone, a medication used to reverse the effects of opioid overdose, and discovering new and safer pain medications.

FDA also released draft guidance in March 2016 for evaluating abuse deterrence of generic solid oral opioid drugs. The guidance is intended for those submitting abbreviated new drug applications (ANDAs) for generic opioid drugs with abuse deterrent properties. The guidance recommends drug developers follow a tier-based approach when conducting in-vitro studies and other tests on generic solid oral opioid drugs.

Source: FDA