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(Add comments from members of the Advisory Committee, based on opioids)
By Saumya Joseph and Ankur Banerjee
October 11 (Reuters) – Trevena Inc.'s Opioid Injection for Acute Pain Management was Not Held Thursday by a Food and Drug Administration Advisory Committee, While Opioid Dependence in the United States Reaches an epidemic proportion.
The panel voted 8-7 against the approval of treatment administered in hospitals and outpatient surgery centers and aims to manage acute pain in patients for whom an intravenous opioid is needed.
The narrow outcome of the vote highlighted not only the concern to introduce another opioid on the market, but also the need for alternatives to current pain treatments.
Opioid addiction is a serious public health crisis in the United States and caused more than 70,000 deaths last year. The regulator has pushed drug manufacturers to look for alternatives, while refusing to allow a number of new opioid drugs.
"We simply do not have enough safety data to say that we are not going to inadvertently harm people," said Mary Ellen McCann, committee member and associate professor of the University of Toronto. Harvard School of Anesthesia Medicine.
"If this drug is produced in another semester or year with better data, I would be very happy to vote yes."
The committee sought more data on proposed doses, safety, and studies of the potential risks to public health related to treatment, which raised concerns about its improper use.
Trevena oliceridine belongs to the same class of opioids as commonly prescribed analgesics, such as morphine and fentanyl.
Panel vote comes two days after FDA reviewers said the global assessment of abuse data suggested the treatment had the potential for abuse and overdose and could lead to physical dependence similar to other treatments of this type.
"I did not see anything today that could indicate that it was better than morphine, but I certainly did not think I saw anything that made it more dangerous than morphine," he said. said Kevin Zacharoff, a committee member who voted for the drug.
The FDA will decide the fate of oliceridine by November 2nd. The regulator is not obliged to comply with the recommendations of the panel, but generally does.
Transactions in the company's shares have been stopped. (Report of Saumya Sibi Joseph and Ankur Banerjee in Bengaluru, edited by Sriraj Kalluvila and Arun Koyyur)
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