A new implant device probuphine, used to treat opioid addiction won approval from the U.S. Food and Drug Administration (FDA). It is the first sub-dermal implant that contains the medication buprenorphine designed to help treat symptoms in people addicted to heroin and prescription drug users. For opioid dependence, with a low dose of buprenorphine will provided for patient for six months as part of medication assisted treatment (MAT).
The device is approved for patients using stable on low to moderate doses of other buprenorphine forms. They are inserted under the skin of a patient’s upper arm by a certified healthcare provider. It delivers a constant low dose of buprenorphine for 6 months, at the end it is surgically removed.
FDA says, clinical testing of the new implant was as effective as buprenorphine in sublingual-film form, 63% of patients having no evidence of opioid in use of Six months usage compared with 64% of patients taking the sublingual form. It must be regulated by a trained professional and it having a risk of abuse if removed from the skin, FDA is needs a Risk Evaluation and Mitigation Strategy (REMS) for the drug.
Advisory committee of FDA narrowly backed the approval of the implant in a 12-5 vote. Supporters said the new implant has advantages over pills because of the reason that, it is implantable and harder to abuse. Others said the drug needs further study and its price is high compared to buprenorphine pills.
The most common side effects of the implant are pain, itching and redness around implant area and other symptoms such as headache, depression, constipation and nausea. The device has a boxed warning during insertion and removal procedures that includes the risk of implant migration, protrusion, expulsion and nerve damage. Recently FDA also approves 3D Mammography with Siemens DBT Platform
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