Of note, the most commonly reported treatment-emergent adverse events for Xanax XR were sedation, somnolence, memory impairment, fatigue, depression, dysarthria, impaired coordination, cognitive impaimient, ataxia, and addiction com hydrocodone isaiah site decreased libido. The most commonly reported discontinuation-emergent adverse events for Xanax XR were anxiety, tremor, dizziness, headache, insomnia, depression, decreased appetite, hyperventilation, and derealization. It should be noted that all 5 ofthe placebo-controlled phase 2-3 clinical studies in panic disorder included long periods of tapering and withdrawal fromXanax XR (5-6 weeks). This development program included reports for studies comparing abuse liability ofXanaxXR, Xanax IR, and several other benzodiazepines on "liking" measures among subjects with hydrocodone sniff histories of. The sponsor's conclusion from the liking studies was thatXanaxXR falls between Xanax IR and placebo, and hydrocodone sniff on this basis, they have proposed language in labeling declaring this advantage. Comment: I think these studies maybe inadequate to support such a claim, and I have asked that these data be sent to CSS for a consult. 5.2.2Conclusions Regarding Safety of Xanax XR in Panic Disorder There were hydrocodone sniff no new safety findings to suggest a different safety profile for Xanax XR inpanic disorder compared to that seen with Xanax IR. 5.3 Clinical Sections of Labeling We have modified the clinical sections ofthe draft labeling that is included with the approvable letter.
The explanations for the changes are provided in bracketed comments in the draft labeling. 6.0WORLD LITERATURE The sponsor provided a literature review focused on Xanax XR and panic disorder. Levin examined a review of this literature provided by the sponsor and indicated that it revealed no new safety hydrocodone sniff findings that would impact on die labeling ofXanaxXR.
He also conducted a somewhat more limited independent literature review and reached a similar conclusion. 7.0 FOREIGN REGULATORY ACTIONS Xanax XR is approved for use in 51 countries, for indications including panic disorder, among a variety of other disorder. It has never been refused approval for safety reasons, or removed from marketing for safety reasons. We will ask for an update on the regulatory status of Xanax XR for the treatment of panic disorder in the approvable letter.
8.0 PSYCHOPHARMACOLOGICAL DRUGS ADVISORY COMMITTEE (PDAC) MEETING We decided not to take this NDA to the PDAC. 9.0DSI INSPECTIONS As noted above, all 3 sites for study 369 were inspected, with positive findings atone site that led to a re-analvsis without the data from that site (see efficacy above). 10.0LABELING AND APPROVABLE LETTER 10.1Final Draft of Labeling Attached to Approvable Package Our proposed draft of labeling is attached to the approvable letter. As noted, we have made changes to the sponsor's draft dated 12-26-01. 10.2Foreign Labeling No foreign labeling was included with this NDA; we will ask for this in the approvable letter.
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