US FDA Proactively Exploring Hydexor Abuse Potential Ahead Of Ad Comm For Anti-Emetic/Opioid Combo
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.
You may also be interested in...
Agency would be allowed to require blister packaging for approved opioids, and would have to do more to coordinate with US Customs and Border Protection to detect illicit drugs at the border, under legislative proposals unveiled by Senate HELP Committee Chairman Lamar Alexander.
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.
Many of the advisory panel members felt the company's proposed buy-back program could not be feasible in practice.