HAL study compared subjective effects of drug liking, drug high and good drug effects between MNK-155 and an immediate-release hydrocodone bitartrate/acetaminophen formulation in non-dependent recreational drug users
In the HAL study, intact and crushed MNK-155 demonstrated statistically significant (p <0.001) lower measures of drug liking, drug high and good drug effects compared with comparable doses of intact immediate-release hydrocodone bitartrate/acetaminophen when measured at the peak drug effect (Emax). It also took significantly longer for intact and crushed MNK-155 to reach peak drug effect compared with intact immediate-release hydrocodone bitartrate/acetaminophen for each of these three measures (p ≤0.029).
MNK-155 is an investigational extended-release oral formulation of
hydrocodone and acetaminophen being studied for the management of
moderate to moderately severe acute pain where the use of an opioid
analgesic is appropriate. MNK-155 is formulated with both immediate- and
extended-release components and was recently awarded patent protection
covering its unique design, formulation, pharmacokinetic, and release
characteristics. The NDA for MNK-155 was accepted for review by the
“All patients experience pain differently, and there is no ‘one size
fits all’ approach to acute pain treatment. It is essential that
patients who warrant treatment for legitimate acute pain have options
and access to appropriate pain medications prescribed by a physician,”
said Dr.
HAL studies are included in the FDA’s Guidance for Industry:
Abuse-Deterrent Opioids - Evaluation and Labeling (
HAL Study Details
The HAL study was a single-center, randomized, double-blind, double-dummy, active- and placebo-controlled 7-way crossover study assessing the abuse potential of orally-administered MNK-155 in 52 healthy male and female non-dependent recreational opioid users. During the seven treatment periods, subjects received a single treatment with one of the seven study drugs:
The study evaluated certain subjective effects that have been associated with drug abuse. The primary outcome measures were 100-point VAS of subject-reported drug liking, drug high and good drug effects, with intact and crushed MNK-155 demonstrating statistically significant (p <0.001) lower measures, compared with comparable doses of intact immediate-release hydrocodone bitartrate/acetaminophen when measured at the peak drug effect (Emax). It also took significantly longer for intact and crushed MNK-155 to reach peak drug effect compared with intact immediate-release hydrocodone bitartrate/acetaminophen for each of these three measures (p ≤0.029). The most common adverse events associated with the use of MNK-155 included nausea, vomiting, pruritus, headache and dizziness.
Vicodin® is a registered trademark of
About
Source:
Mallinckrodt
Lynn Phillips, 314-654-3263
Manager, Media
Relations
lynn.phillips@mallinckrodt.com
or
Meredith
Fischer, 314-654-6595
Senior Vice President, Communications
meredith.fischer@mallinckrodt.com
or
John
Moten, 314-654-6650
Vice President, Investor Relations
john.moten@mallinckrodt.com