FDA Approves Probuphine as the first Long-time Opioid Treatment
Earlier this year USFDA (U.S Food and Drug Administration) committee supported the approval of Probuphine, the first buprenorphine implant maintenance treatment of opioid dependence. Probuphine made to provide a constant low-level dose of buprenorphine in patients for six months who already have stabilized low-to-moderate forms of buprenorphine.
Until today, the buprenorphine was only approved as a pill placed under the tongue or a person's cheek till it dissolved. A pill or film may forget, lost, or stolen. However, Probuphine as an implant provides a new treatment option for people who values unique benefits of a six-month implant such as the improvement of patient's convenience from not needing to intake medication on daily basis.
According to Robert M Califf, the FDA commissioner said: The abuse and addiction of Opioid have taken a devastating toll on the American families. The approval of the new innovative treatment is important to help patients regain their control over their lives and the first implantable option to sustain patient's effort to maintain the treatment as part of the overall recovery program, according to FDA.
In implanting the Probuphine, it is placed in the upper arm, the procedure takes almost 10 to 15 minutes. The patient might feel slight reactions like pain, itching, redness and swelling. But it has common side effects like headache, depression, constipation, nausea, vomiting , abdominal pain, toothache, and oropharyngeal pain, Health Day reports.
Health care professional gives a warning and advice in the insertion and removal of the drug. Probuphine has a corresponding risk of implant migration, protrusion, expulsion and nerve damage from the procedure. As part of the program, Probuphine can only be dispensed and prescribed by the health care providers who are certified with REMS program and completed the training.
Probuhpine is marketed by Titan Pharmaceuticals Inc, San Francisco-based, and Braeburn Pharmaceuticals in Princeton, New Jersy. FDA is responsible for the safety and security of nations different products.
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