Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
45-mg hydrocodone bitartrate · 1 trial · 1 indication
The DLEQ measures positive, negative, and any drug effects using bipolar and unipolar VAS. Bipolar VAS range from a strong negative response (score of 0) to a strong positive response (score of 100) with a neutral midpoint (score of 50). Unipolar VAS range from a response of 'none' (score of 0) to 'extremely' (score of 100). Questions include assessments of liking, drowsiness, good effects, bad effects, nausea,and any effects. The primary outcome is question 1 which states: "My liking for this drug is:"
| Arm | Type | Description |
|---|---|---|
| BCAD Treatment Group | EXPERIMENTAL | Subjects in this group will receive study drug in the following sequence: Treatment B - 1 intact placebo tablet, hydrocodone bitartrate powder at a dose strength of 45 mg reconstituted in 60 mL of a noncarbonated flavored beverage, and 1 crushed placebo tablet. Treatment C - 1 intact 45-mg hydrocodone bitartrate extended-release tablet, 60 mL of a noncarbonated flavored beverage, and 1 crushed placebo tablet. Treatment A - 1 intact placebo tablet, 60 mL of a noncarbonated flavored beverage, 1 crushed 45-mg hydrocodone bitartrate extended-release tablet. Treatment D - 1 intact placebo tablet, 60 mL of a noncarbonated flavored beverage, and 1 crushed placebo tablet(matching the 45-mg hydrocodone bitartrate extended-release tablet). |
| CDBA Treatment Group | EXPERIMENTAL | Subjects in this group will receive study drug in the following sequence: Treatment C - 1 intact 45-mg hydrocodone bitartrate extended-release tablet, 60 mL of a noncarbonated flavored beverage, and 1 crushed placebo tablet. Treatment D - 1 intact placebo tablet, 60 mL of a noncarbonated flavored beverage, and 1 crushed placebo tablet (matching the 45-mg hydrocodone bitartrate extended-release tablet). Treatment B - 1 intact placebo tablet, hydrocodone bitartrate powder at a dose strength of 45 mg reconstituted in 60 mL of a noncarbonated flavored beverage, and 1 crushed placebo tablet. Treatment A - 1 intact placebo tablet, 60 mL of a noncarbonated flavored beverage, 1 crushed 45-mg hydrocodone bitartrate extended-release tablet. |
| DACB Treatment Group | EXPERIMENTAL | Subjects in this group will receive study drug in the following sequence: Treatment D - 1 intact placebo tablet, 60 mL of a noncarbonated flavored beverage, and 1 crushed placebo tablet(matching the 45-mg hydrocodone bitartrate extended-release tablet). Treatment A - 1 intact placebo tablet, 60 mL of a noncarbonated flavored beverage, 1 crushed 45-mg hydrocodone bitartrate extended-release tablet. Treatment C - 1 intact 45-mg hydrocodone bitartrate extended-release tablet, 60 mL of a noncarbonated flavored beverage, and 1 crushed placebo tablet. Treatment B - 1 intact placebo tablet, hydrocodone bitartrate powder at a dose strength of 45 mg reconstituted in 60 mL of a noncarbonated flavored beverage, and 1 crushed placebo tablet. |
| ABDC Treatment Group | EXPERIMENTAL | Subjects in this group will receive study drug in the following sequence: Treatment A - 1 intact placebo tablet, 60 mL of a noncarbonated flavored beverage, 1 crushed 45-mg hydrocodone bitartrate extended-release tablet. Treatment B - 1 intact placebo tablet, hydrocodone bitartrate powder at a dose strength of 45 mg reconstituted in 60 mL of a noncarbonated flavored beverage, and 1 crushed placebo tablet. Treatment D - 1 intact placebo tablet, 60 mL of a noncarbonated flavored beverage, and 1 crushed placebo tablet(matching the 45-mg hydrocodone bitartrate extended-release tablet). Treatment C - 1 intact 45-mg hydrocodone bitartrate extended-release tablet, 60 mL of a noncarbonated flavored beverage, and 1 crushed placebo tablet. |
| Name | Type | Description |
|---|---|---|
| 45-mg hydrocodone bitartrate extended-release tablet (crushed or intact) | DRUG | Phase B: Eligible subjects will be randomized to treatment sequence XY or YX whereby treatment X is 60 mL of a noncarbonated flavored beverage and treatment Y is hydrocodone bitartrate powder at a dose strength of 45-mg reconstituted in 60 mL of a noncarbonated flavored beverage. Phase C: Eligible subjects will be randomly assigned to 1 of 4 treatment arms: Treatment A: intact placebo tablet, 60 mL noncarbonated flavored beverage, 1 crushed 45-mg hydrocodone bitartrate extended-release tablet. Treatment B: intact placebo tablet, hydrocodone bitartrate powder at a dose strength of 45-mg in 60 mL of a noncarbonated flavored beverage and 1 crushed placebo tablet. Treatment C: intact 45-mg hydrocodone bitartrate extended-release tablet, 60 mL noncarbonated flavored beverage, and 1 crushed placebo tablet Treatment D: intact placebo tablet, 60 mL noncarbonated flavored beverage, and 1 crushed placebo tablet. |
| Placebo | DRUG | Placebo will consist of 60 mL of a non-carbonated beverage without the addition of active treatment |
Inclusion Criteria: * Written informed consent is obtained. * The subject speaks and writes in English. * The subject is not physically dependent on opioids as demonstrated by successful completion of a naloxone challenge; ie, subject does not exhibit signs or symptoms of opioid withdrawal (as asse...
45-mg hydrocodone bitartrate is an investigational extended-release tablet formulation of the opioid hydrocodone, developed by Teva Pharmaceutical Industries Limited. It was studied in a Phase 1 trial assessing abuse potential in recreational opioid users, evaluating both crushed and intact tablet forms. It is not an approved product.
45-mg hydrocodone bitartrate was studied in the context of drug abuse research, specifically to assess its abuse potential in recreational opioid users. The single Phase 1 trial enrolled 100 participants and evaluated the extended-release tablet in both crushed and intact forms. It is not approved for any indication.
45-mg hydrocodone bitartrate is developed by Teva Pharmaceutical Industries Limited, which trades under the ticker TEVA. Teva sponsored the Phase 1 abuse potential study of this extended-release hydrocodone formulation.
45-mg hydrocodone bitartrate is in Phase 1 development. The only clinical trial of this formulation was a completed Phase 1 study assessing abuse potential in recreational opioid users. It is investigational and has not been approved by the FDA.
45-mg hydrocodone bitartrate was evaluated in one completed Phase 1 trial, NCT01596673, titled "A Study to Assess the Abuse Potential of Hydrocodone Extended-Release Tablet in Recreational Opioid Users." The randomized, double-blind, controlled study enrolled 100 participants across the United States and Canada.