Drugs

FDA Approves Drug Implant for Opioid Dependence

FDA has approved a Titan Pharmaceuticals Inc. and Braeburn Pharmaceuticals NDA for Probuphine (buprenorphine), an implant for maintenance treatment of opioid dependence. The product is designed to provide a “constant, low-level dose of buprenorphine for six months in patients who are already stable on low-to-moderate doses of other forms of buprenorphine, as part of a complete treatment program,” an FDA release says.

Previously, buprenorphine was approved as a pill or a sublingual film. “While effective, a pill or film may be lost, forgotten or stolen,” FDA says. “However, as an implant, Probuphine provides a new treatment option for people in recovery who may value the unique benefits of a six-month implant compared to other forms of buprenorphine, such as the possibility of improved patient convenience from not needing to take medication on a daily basis. An independent FDA advisory committee supported the approval of Probuphine in a meeting held earlier this year.”

Approval was based on data from a randomized clinical trial in adults who met the clinical criteria for opioid dependence and were considered stable after prior buprenorphine treatment. “Sixty-three percent of Probuphine-treated patients had no evidence of illicit opioid use throughout the six months of treatment – similar to the 64% of those who responded to sublingual (under the tongue) buprenorphine alone,” FDA says. The most common side effects included implant-site pain, itching, and redness, as well as headache, depression, constipation, nausea, vomiting, back pain, toothache and oropharyngeal pain.

The drug has a boxed warning that discusses the insertion and removal of Probuphine are associated with the risk of implant migration, protrusion, expulsion and nerve damage resulting from the procedure. “Probuphine must be prescribed and dispensed according to the Probuphine REMS program because of the risks of surgical complications and because of the risks of accidental overdose, misuse and abuse if an implant comes out or protrudes from the skin,” the agency says. “As part of this program, Probuphine can only be prescribed and dispensed by health care providers who are certified with the REMS program and have completed live training, among other requirements.

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Gupta Raises Concerns About Overton’s Independence, Ideology

Overton Confirmation Remains Uncertain After Senate Hearing

FDA Classifies Boston Scientific Imager II Catheter Recall as Class I

FDA Approves Gazyva for Childhood-Onset Idiopathic Nephrotic Syndrome