Abuse-deterrent properties do not prevent or reduce the risk of addiction¹

Evaluated by a clinical intranasal abuse potential study

Statistically lower Drug Liking and Take Drug Again mean and median scores were reported with manipulated Hysingla ER compared with powdered hydrocodone (P<.001)

Design of intranasal abuse potential study

• Randomized, double-blind, placebo and active comparator study
• Treatments studied included intranasally administered manipulated Hysingla ER 60 mg tablets, powdered hydrocodone bitartrate 60 mg, and placebo
• 31 subjects dosed, 25 subjects completed study
  • Subjects chosen were non-physically dependent abusers of prescription opioids; subjects were not liable to opioid-withdrawal effects²

Incomplete dosing due to granules falling from the subjects' nostrils occurred in 82% (n=23) of subjects receiving manipulated Hysingla ER compared to no subjects with powdered hydrocodone or placebo, which may have impacted the results.

Results of intranasal abuse potential study

Drug Liking was measured on a bipolar drug-liking scale of 0 to 100, where 50 represents a neutral response of neither liking nor disliking, 0 represents maximum disliking, and 100 represents maximum liking.

• The mean and median Drug Liking scores for subjects administered manipulated Hysingla ER intranasally were statistically lower than the scores for subjects administered hydrocodone powder (P<.001)

Response to whether the subject would take the study drug again was measured on a unipolar scale of 0 to 100 where 0 represents the strongest negative response ("definitely would not take drug again") and 100 represents the strongest positive response ("definitely would take drug again").

• The mean and median Take Drug Again scores for subjects administered manipulated Hysingla ER intranasally were statistically lower than the scores for subjects administered hydrocodone powder (P<.001)

Percent reduction profiles for peak Drug Liking scores for manipulated Hysingla ER compared with hydrocodone powder following intranasal administration (n=25)

• Approximately 80% (n=20) of subjects had some reduction in Drug Liking with manipulated Hysingla ER relative to hydrocodone powder
• 68% (n=17) of subjects had a reduction of at least 30% in Drug Liking with manipulated Hysingla ER compared with hydrocodone powder
• Approximately 64% (n=16) of subjects had a reduction of at least 50% in Drug Liking with manipulated Hysingla ER compared with hydrocodone powder
• Approximately 20% (n=5) of subjects had no reduction in Drug Liking with manipulated Hysingla ER relative to hydrocodone powder

• Abuse of Hysingla ER by the intravenous, intranasal, and oral routes is still possible