FDA Advisory Committee Denies Charleston Laboratories’ Hydexor

Posted by on February 20, 2018

On February 14th, 2018 a joint meeting of the Anesthetic and Analgesic Drug Products Advisory Committee (AADPAC) and the Drug Safety and Risk Management Advisory Committee (DSaRM) reviewed new drug application (NDA) 209257 for Charleston Laboratories’ novel pain drug, Hydexor. Hydexor is a fixed-dose combination oral tablet containing hydrocodone, acetaminophen, and promethazine for the treatment of acute pain in those suffering from enough pain to require an opioid analgesic, while preventing opioid-induced nausea and vomiting (OINV).

Many patients experience OINV when prescribed opioid products for the management of acute pain. Promethazine, one of the active drug substances in Hydexor, provides antiemetic benefits, mitigating OINV. If approved, Hydexor would be the first opioid product to include an antiemetic agent in the formulation.

The sponsor presented data from their clinical program, which included three phase 1 bioavailability studies and two phase 3 studies. Upon completion of the presentation segment of the meeting, panel members expressed concern over the side effects of Hydexor, which included participants feeling dizzy, drowsy, and confused. Given that these side effects were the most common adverse events reported in the sponsor’s clinical program, panel members questioned the prophylactic use of promethazine for OINV. Panelists also expressed concern over the sponsor’s approach to marketing only one strength of Hydexor, prompting the discussion of whether single strength is useful for certain patient needs.

When asked by the FDA if Hydexor should be approved for marketing in the US, panel members voted against approval, 2 (yes) and 19 (no).

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