Opioid dependence may now be treated with Probuphine implant, as the U.S Food and Drug Association (FDA) green lights its use.
On May 26, the FDA approved the use of the first buprenorphine implant - Probuphine - as a maintenance therapy for opioid dependence.
Prior to its approval, buprenorphine was sold as a tablet or a sublingual film. Since its film or pill form can be easily lost or stolen, the agency decided to approve its implant form. A Probuphine implant will provide six months of constant, low-dose coverage of buprenorphine. It is recommended for individuals who are already on steady, low doses of buprenorphine and who are looking for a more convenient opioid therapy.
FDA Commissioner Robert Califf acknowledged that opioid use and dependence are ruining the lives of many individuals and part of their role is to continuously look for new and innovative therapies to help these patients take control of their lives again.
"Today's approval provides the first-ever implantable option to support patients' efforts to maintain treatment as part of their overall recovery program," said Califf.
Opioid Action Plan
The approval is a top priority of the U.S. Department of Health and Human Services' Opioid Initiative and an important part of the FDA's opioids action plan that aim to decrease cases of addiction, overdose and death related to opioid use.
Medication-assisted treatment (MAT) is a holistic approach to treat opioid dependence. Behavioral treatments including counseling are augmented with the use of MAT such as buprenorphine. Patients who constantly use MAT are noted to cope better with symptoms of withdrawal and have a reduced death risk of 50 percent.
"Scientific evidence suggests that maintenance treatment with these medications in the context of behavioral treatment and recovery support are more effective in the treatment of opioid use disorder than short-term detoxification programs aimed at abstinence," said Nora Volkow, M.D., director of the National Institute on Drug Abuse at the National Institutes of Health. Volkow believes that Probuphine will widen treatment choices for patients suffering from opioid dependence.
Probuphine Side Effects
The use of Probuphine for children and adolescents aged 16 years old and below is not recommended as its efficacy and safety for the said age groups have not been studied. Patients aged 65 years old and above were also not part of Probuphine clinical studies.
Use of Probuphine has minimal side effects including pain on site of implant, skin redness and itching, constipation, headache, nausea and vomiting, toothache and back pain. Probuphine can also cause depression.
Recommendations For Use
Health care providers with Risk Evaluation and Mitigation Strategy (REMS) program certification are the only ones allowed to prescribe and dispense Probuphine. Patients must be informed about the associated risks such as protrusion, nerve damage and risk of implant migration and that the implants contain drugs that may be removed, which can cause exposure or misuse.
Patients on Probuphine must see their health care provider a week after the insertion and must attend monthly counseling and other behavioral therapies.
In an earlier Tech Times report, the New York Senate outlined its plan of combating the growing problem of opioid abuse.
