FDA panel favors combo IR opioid
By a vote of 16 to 4, an FDA panel has recommended approval of a new immediate-release (IR) pain formulation that includes benzhydrocodone hydrochloride (HCl) and 325 mg of acetaminophen. However, the panel rejected the abuse-deterrent labeling for the new drug by a vote of 18 to 2.
On May 5, 2016, the FDA Center for Drug Evaluation and Research (CDER) held a joint meeting of the Anesthetic and Analgesic Drug Products Advisory Committee (AADPAC), and Drug Safety and Risk Management Advisory Committee (DSaRM) to review KemPharm's new drug application for the product KP201/APAP ( proposed name: Apadaz). The manufacturer was seeking a recommendation for approval of the IR opioid analgesic, and requesting abuse-deterrent labeling based on company studies.
The committee members were asked to consider three draft points when voting on the applicant’s drug approval and labeling determinations.
• Did the data show "that the nasal route of abuse is relevant for combination products such as theirs that contain hydrocodone and acetaminophen"?
• Did KP201 demonstrate properties "that would be expected to deter abuse through both IV and nasal administration"?
• Did the data support inclusion of "abuse-deterrent language on the label for both IV and nasal administration"?
KemPharm presents its case
During the meeting, KemPharm President and CEO Travis Mickle, PhD, described Apadaz as “a new molecular entity.” He described benzhydrocodone HCl as “a prodrug that is inert when taken orally ... and is rapidly metabolized in the gastrointestinal (GI) tract as an immediate-release drug.” Enzymes in the GI tract allow it to bind to receptors, which the company says allows the drug to offer “abuse-deterrent features but does not pose risk for being a treatment for pain.”
The immediate-release and abuse-deterrent properties of KP201 as intended by the manufacturer are of special interest to FDA. A year ago the agency issued final guidance to assist industry in the “development of opioid drug products with potentially abuse-deterrent properties,” citing the market absence of any “existing single-entity or combination immediate-release opioid analgesics labelled with abuse-deterrent properties."
At present, five extended-release/long-acting opioid analgesic products have labeling that includes language and studies covering abuse-deterrent properties; no IR products currently have such labeling.