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(Reuters) – Trevena Inc.'s opioid injection for the treatment of acute pain could be abused and lead to overdose, US Food and Drug Administration rapporteurs said Tuesday, sending 66% of its patients actions to the manufacturer.
The treatment, oliceridine, is aimed at treating moderate to severe acute pain in adult patients for whom an intravenous opioid is needed, and the injection should be administered in hospitals and outpatient surgery centers.
FDA evaluators stated: https://www.fda.gov/downloads/AdvisoryCommittees/CommitteesMeetingMaterials/Drugs/AnestheticAndAnalgesicDrugProductsAdvisoryCommittee/UCM622730.pdf, an overall assessment of abuse data from studies suggesting that the Trevena was defending the physical addiction that is similar to other treatments of this type.
Olericin belongs to a class of opioids including morphine and fentanyl, which are commonly prescribed to relieve pain.
An expert panel of the FDA is expected to decide Thursday on the effectiveness and safety of treatment. Their meeting comes at a time when the abuse of opioids has reached epidemic proportions.
Opioid addiction – mainly heroin and fentanyl, a prescription pain reliever – has become a serious public health crisis in the United States, particularly in rural areas, resulting in more than 70,000 deaths in the United States last.
Although the FDA is not obliged to follow the panel's advice, it does so generally.
Trevena's shares traded at 99 cents before the bell on Tuesday. The company's shares have increased 86% this year.
(Report by Ankur Banerjee in Bengaluru, edited by Anil D & # 39; Silva)
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