CV Trials Not Required for PAMORAS Class, Votes FDA Committee
The Anesthetic and Analgesic Drug Products Advisory Committee of the FDA has voted to not require cardiovascular outcomes trials (CVOTs) for peripherally-active opioid receptor antagonists (PAMORAS) that are being developed for the treatment of opioid-induced constipation in patients with chronic non-cancer pain.
The Committee provided an assessment of potential cardiovascular risk associated with products in the PAMORAS class of drugs and recommendations regarding the necessity, timing, design, and size of CVOTs to support approval of drugs in this class for the proposed indication. Also, the Committee recommended that observational studies be conducted on a post-marketing basis.
Twelve Committee members voted to not require CVOTs for PAMORAS being developed for this specific indication. Seven members voted to require CVOTs for all PAMORAS, and five members voted to require CVOTs for specific PAMORAS.
PAMORAS block opioids from binding to mu-opioid receptors in tissues such as the gastrointestinal tract to inhibit their constipating effects.
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