FDA seeks advice on opioid-induced constipation drugs’ risks

The FDA is convening a panel of its outside advisers over two days on 11-12 June to help the agency flesh out whether to require cardiovascular outcomes trials (CVOTs) for all, only specific or none of the peripherally active mu opioid receptor antagonists being developed to treat opioid-induced constipation (OIC) in patients with chronic non-cancer pain.

The FDA is convening a panel of its outside advisers over two days on 11-12 June to help the agency flesh out whether to require cardiovascular outcomes trials (CVOTs) for all, only specific or none of the peripherally active mu opioid receptor antagonists being developed to treat opioid-induced constipation (OIC) in patients with chronic non-cancer pain.

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