Mallinckrodt Pharmaceuticals Releases Human Abuse Liability (HAL) Data For Investigational MNK-155, An Extended-Release Hydrocodone/Acetaminophen Combination

Mallinckrodt

today reported data from a Human Abuse Liability (HAL) study in which both intact and crushed MNK-155 showed lower subjective abuse-related effects than an immediate-release hydrocodone bitartrate/acetaminophen formulation (a generic form of Vicodin®). The data will be presented at PAINWeek 2014, a national conference on pain for frontline practitioners, in Las Vegas, Nevada September 2-6, 2014. 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 U.S. Food and Drug Administration (FDA) in May 2014. “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. Lynn Webster, Vice President, Scientific Affairs, PRA HEALTH SCIENCES. “The HAL study data of MNK-155 presented at PAINWeek are encouraging and warrant further study of this formulation.” HAL studies are included in the FDA's Guidance for Industry: Abuse-Deterrent Opioids - Evaluation and Labeling (January 2013). These studies are an important tool for the FDA to assess the relative abuse potential of a new drug. For drugs with abuse-deterrent properties, a HAL study assesses the impact of the potentially abuse-deterrent formulation on measures that predict how probable it is that the medication will be attractive to abusers. The industry guidance recommends that a Visual Analog Scale (VAS) be used to measure drug liking, drug high, good drug effects and other qualities.