San Diego — MediciNova, Inc., a biopharmaceutical company, has received a Notice of Allowance from the U.S. Patent and Trademark Office for a pending patent application, which covers the use of Ibudilast for the treatment of drug addiction or drug dependence or withdrawal syndrome.
Ibudilast (MN-166 or AV411) is the company's lead drug candidate for certain neurological conditions, including neuropathic pain, drug addiction and progressive multiple sclerosis.
The patent, once issued, covers the use of ibudilast for therapeutic administration alone or in combination with other drugs for the treatment of opioid addiction, dependence, or withdrawal syndrome.
Ibudilast is a non-opioid inhibitor of macrophage migration inhibitory factor (MIF) and phosphodiesterases-4 and -10 (PDEs-4, -10) and has been shown to reduce glial cell activation. Such a cellular action has been experimentally linked to certain neurochemical and behavioral changes associated with addiction to drugs like opioids and methamphetamine.
The patent application is based upon research by Linda Watkins, PhD, and colleagues at University of Colorado, Boulder, and Kirk Johnson, PhD, Chief Scientific Officer, at MediciNova.
As mentioned above, the allowed claims include a method of treating an opioid withdrawal syndrome, which is sometimes observed in patients who stop or reduce their use of opioids like morphine and oxycodone (i.e., Vicodin), and the reduction of associated glial cell activation. The allowed claims also cover the use of ibudilast in combination with buprenorphine, itself an opioid, which is approved (i.e., Suboxone) for treating opioid dependence.
Yuichi Iwaki, MD, PhD, President and CEO of MediciNova, noted that "We are very pleased to receive notice of this patent allowance for ibudilast in drug addiction, especially on the heels of our recent announcement of encouraging preliminary clinical trial results in morphine withdrawal and analgesia."
Dr. Iwaki added that "Positive progress in our MN-166 program along with our ongoing phase 2 asthma exacerbation trial with another of our lead drug candidates, MN-221, speaks to our pipeline quality."
Ibudilast has been used in asthma and post-stroke disorders in Japan for nearly 20 yrs and has also been utilized at higher doses with encouraging outcomes in company-sponsored clinical trials in multiple sclerosis and neuropathic pain.