Pain Therapeutics said on Monday that the U.S. Food and Drug Administration declined to approve its opioid drug for the management of severe pain as the benefits of the drug did not outweigh the risk.
"This is a bizarre conclusion to reach, especially during a time of staggering human and economic toll created by opioid abuse and addiction," said Chief Executive Officer Remi Barbier said in a statement.
The FDA's "complete response letter" marks the latest setback to the U.S. drug developer and the treatment, Remoxy ER, which has failed to get marketing approval on the past three attempts.
The drug developer also said it had initiated a strategic reorganization to align its resources to focus on its treatments and diagnostic products for Alzheimer's disease.
The drug is a capsule formulation of the commonly-used opioid oxycodone
The regulator's decision comes amid increased public and regulatory scrutiny in the United States over the use of opioid drugs, the abuse of which has reached epidemic proportions in the country.
"I believe Remoxy received an ideological judgement call that is vague in nature but conclusive in its damaging effects," Barbier said.
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