FDA Approves Implant Device to Treat Opioid Addiction

May 31, 2016

On Thursday, May 26th, FDA announced the approval of Probuphine® , a buprenorphine implant for the treatment of opioid dependence.  The implant is the first device of its kind, and “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.”

Prior to Probuphine’s approval, buprenorphine was only available as a pill or a film placed under the tongue or on the inside of a person’s cheek until dissolved.  The FDA stated that the implant “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.”

According to the FDA’s recent press release, “Probuphine should be used as part of a complete treatment program that includes counseling and psychosocial support. Probuphine consists of four, one-inch-long rods that are implanted under the skin on the inside of the upper arm and provide treatment for six months. Administering Probuphine requires specific training because it must be surgically inserted and removed. Only a health care provider who has completed the training and become certified through a restricted program called the Probuphine Risk Evaluation and Mitigation Strategy (REMS) program should insert and remove the implants. If further treatment is needed, new implants may be inserted in the opposite arm for one additional course of treatment. The FDA is requiring postmarketing studies to establish the safety and feasibility of placing the Probuphine implants for additional courses of treatment.”

Common side effects associated with the use of Probuphine include headaches, depression, constipation, nausea, vomiting, back pain, toothache, and oropharyngeal pain, as well as implant-site pain, itching, and redness.  The implant is accompanied by a boxed warning that contains important safety information for health care professionals.  The warning notes that the “insertion and removal of Probuphine are associated with the risk of implant migration, protrusion, expulsion and nerve damage resulting from the procedure.”

In its press release, the FDA stated that Probuphine’s approval is an important part of its action plan to overcome the opioid epidemic in the US.  For additional information on the opioid epidemic view our FDA News article, entitled “Opioid Epidemic: Everything You Need to Know About FDA’s Action Plan to Reduce Opioid Abuse.”

Are you in the process of developing an FDA-regulated product? We can help you achieve a successful interaction with the FDA and obtain marketing approval.  To learn more about our services and how we can help you, contact us today.


Tobacco sticking out of cigarettes

December 1, 2015

FDA Extends Comment Period for Proposed Regulation of Intended Uses of Tobacco Products

On September 25, 2015, FDA published a notice of proposed rulemaking (NPRM) regarding the regulation of products made or derived from tobacco. In the Federal Register announcement, "FDA requested...

October 1, 2015

Will FDA Change the Definition of “Intended Use”?

FDA released proposed regulation that would allow sponsors to determine if their product is a drug/device, or if it is not a drug/device. Last week, the Agency announced a proposed rule “to provide...

March 21, 2016

Direct-to-Consumer (DTC) Drug Advertisements, Part Three

FDA’s Proposed Study on Consumer Understanding of Quantitative Information in DTC Drug Ads In October 2015, the FDA announced plans to conduct a study which would determine how much quantitative...