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

Evaluated by a clinical oral abuse potential study

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

Design of oral abuse potential study

• Randomized, double-blind, placebo and active comparator study
• Treatments studied included chewed Hysingla ER 60 mg tablets, intact Hysingla ER 60 mg tablets, 60 mg aqueous hydrocodone bitartrate solution, and placebo
• 40 subjects dosed, 35 subjects completed study
  • Subjects chosen were non-physically dependent abusers of prescription opioids; subjects were not liable to opioid-withdrawal effects²

Results of oral 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 Hysingla ER orally were statistically lower than the scores for subjects administered hydrocodone solution (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 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 Hysingla ER orally were statistically lower than the scores for subjects administered hydrocodone solution (P<.001)

Percent reduction profiles for peak Drug Liking scores for chewed Hysingla ER compared with hydrocodone solution following oral administration (n=35)

• Approximately 80% (n=28) of subjects had some reduction in Drug Liking with chewed Hysingla ER relative to hydrocodone solution
• Approximately 69% (n=24) of subjects had a reduction of at least 30% in Drug Liking with chewed Hysingla ER compared with hydrocodone solution
• Approximately 60% (n=21) of subjects had a reduction of at least 50% in Drug Liking with chewed Hysingla ER compared with hydrocodone solution
• Approximately 20% (n=7) of subjects had no reduction in Drug Liking with chewed Hysingla ER relative to hydrocodone solution

Results of a similar analysis of Drug Liking for intact Hysingla ER relative to hydrocodone solution were comparable to the results of chewed Hysingla ER relative to hydrocodone solution

• Approximately 83% (n=29) of subjects had some reduction in Drug Liking with intact Hysingla ER relative to hydrocodone solution
• 83% (n=29) of subjects had a reduction of at least 30% in peak Drug Liking scores with intact Hysingla ER compared to hydrocodone solution
• Approximately 74% (n=26) of subjects had a reduction of at least 50% in peak Drug Liking scores with intact Hysingla ER compared with hydrocodone solution
• Approximately 17% (n=6) had no reduction in Drug Liking with intact Hysingla ER relative to hydrocodone solution

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