Placebo Effect Raises Questions About Clinical Value For Depomed, Noven Hot Flash Treatments
Advisory Committee for Reproductive Health Drugs asks whether FDA standards are too difficult to meet for non-hormonal products like gabapentin and paroxetine after the placebo arms of both drugs’ trials show a strong reduction in vasomotor symptoms.
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In an NEJM perspective piece, agency reviewers explain why they believed Noven’s paroxetine for treating hot flashes should come to market despite only “modest” efficacy and an advisory committee’s overwhelming recommendation against approval.
Despite the product’s rocky history, Depomed says it is ready to file its non-hormonal hot flash treatment Serada (extended-release gabapentin) based on a recent meeting with FDA. But a mixed Phase III dataset raises doubts about approvability.
With the pre-GDUFA backlog largely acted upon, the FDA expects ANDA approvals to decrease, but supplement actions to increase in FY 2020 and FY 2021.