FDA panel votes against Nektar opioid painkiller
FDA unanimously voted against Nektar Therapeutics opioid pankiller (NKTR-181) for chronic lower back pain, prompting the company to withdraw its application.
It voted 27-0 against the approval over concerns of people abusing the drug. They also felt that there was a lack of data to determine the possible abuse when snorted or injected and its potential for liver toxicity.
Nektar’s NTKR-181 had aimed to relieve pain without triggering euphoria by reducing the rate at which the drug enters the brain. Low back pain is traditionally treated with anti-inflammatory drugs and sometimes opioids if the pain is severe.
The company said that they would stop investing in the program which could save them between $75 million and $125 million throughout 2020.
Explaining the decision, Dr Sherif Zaafran, Vice Chairman of the Clinical Governance board at US Anaesthesia Partners, said: “I voted no even though I liked the idea of what they are trying to do. The data, I don’t think at the end of the day was sufficient from the standpoint of efficacy and safety.”
The FDA has been reluctant to greenlight new opioids due to the opioid epidemic that is ravaging America.
The epidemic has killed nearly 400,000 people since 2000, and has killed more people than HIV at the peak of that disease. Economically it has cost between $50 billion and $1 trillion.
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