US FDA Advisory Cmte. Review Of Charleston's Hydexor Exposes Flaws In Commercial Strategy
Physicians may be hesitant to prescribe the opioid/anti-emetic combo for several reasons; panelists were concerned the company hasn't figured out a specific commercial audience for Hydexor at this point in the review process.
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Charleston Labs is not seeking abuse-deterrent labeling for Hydexor, but FDA has been monitoring online web forums to spot patterns of abuse of the active ingredients to determine if inclusion of promethazine translates to greater risk of abuse than for other hydrocodone products.
After US FDA's Oncologic Drugs Advisory Committee voted to delay approval of Karyopharm's multiple myeloma drug Xpovio, the company submitted some data from the Phase III BOSTON trial, which prompted the FDA to award an accelerated approval for a narrower indication.
Chronicle of the development and review of Karyopharm's Xpovio (selinexor) for the treatment of adult patients with relapsed or refractory multiple myeloma who have received at least four prior therapies.