A phase II clinical trial has shown that a new medication dubbed OMS405, when used in conjunction with buprenorphine and naloxone, reduces cravings and anxiety among people addicted to opiates.
“Development of pharmacological strategies aimed at improving opioid-based treatments of heroin addiction is a major clinical need,” researcher Sandra Comer of Columbia University and New York State Psychiatric Institute said in a news release issued by the drug maker, Omeros.1 “The data with the (peroxisome proliferator-activated receptor)-gamma agonist are encouraging and suggest that it has therapeutic potential for opioid use disorder.”
The study included 30 heroin users who were not seeking treatment. They were admitted to an inpatient unit for up to three weeks. They randomly received OMS405 or placebo daily for up to three weeks, and also were maintained with 8 mg of buprenorphine and 2 mg of naloxone.
Those who received OMS405 had “a statistically significant reduction” in heroin craving compared with placebo and also less anxiety, according to the news release. Researchers said adverse effects were minimal.
The drug is known as a PPAR-gamma agonist. This class of drug has been used to treat diabetes in the past, and it works by prompting the body to metabolize fat.
Class of Drugs Originally Used to Treat Diabetes
Although PPAR-gamma agonists have had limited FDA-approved uses so far, a 2011 study said in the future the drugs could be used to treat everything from obesity to pain to cancer.2 “PPAR are involved in various independent and DNA-dependent molecular and enzymatic pathways in adipose tissue, liver and skeletal muscles,” the paper published in Journal of Advanced Pharmaceutical Technology reported. “These pathways are affected in disease condition and cause the metabolic energy imbalance. Thus, intervention of PPAR can provide therapeutic targets for plethora of diseases such as dyslipidemia, diabetes, obesity, inflammation, neurodegenerative disorder and cancer.”
In addition to reducing anxiety and cravings in people addicted to heroin, it did the same for those addicted to cocaine in a previous phase II trial, the results of which were released earlier this year. OMS405 also is in phase II trials for treating smoking withdrawal, and is in pre-clinical trials for treatment of alcohol withdrawal, according to Adis Insight.3
“These clinical findings are exciting, particularly given that statistically significant improvement was seen on top of the combination of buprenorphine and naloxone, one of the most frequently prescribed treatments for heroin addiction with annual worldwide sales in excess of $1.1 billion,” said Dr. Gregory A. Demopulus, chairman and CEO of Omeros, in the news release. “Heroin abuse affects more than 9 million people worldwide. These clinical data, together with the recently reported discovery of the anti-craving effects and brain white matter protection in patients with cocaine use disorder, demonstrate the potential importance of OMS405 in the fight against the global addiction epidemic.”
Drug Could Fight Relapse in Those with Opioid Use Disorder
The maker of the drug admits in the news release that the drug did not stop people from using heroin in the study, nor did it numb the euphoria of the heroin high. However, in a specialized environment where a patient is treated both for addiction and a co-occurring disorder that drives the addiction, such as mental illness or trauma, a drug like this could improve someone’s chances of long-term success by preventing relapse.
Anxiety often is what drives relapse among people in recovery, according to the Omeros news release.
As if often the case in small clinical trials, the pharmaceutical company put a disclaimer on the release saying it contains “forward looking statements.” This means the reported conclusions still are preliminary and need to be proven further.
With the country in the midst of an opioid epidemic, the development of new medications to treat those in recovery is critical. This class of drug could help reduce the amount of buprenorphine/naloxone needed to maintain a person recovering from opioid addiction. Buprenorphine/naloxone themselves cause dependency and have potential for abuse, and many people in recovery express frustration that they simply have moved from one drug to another.
Still, buprenorphine/naloxone, when used properly, allow opioid addicts to function in daily life and regain control of their lives again.
Comer, who assisted Omeros in the OMS405 research, is one of the nation’s pre-eminent scientists specializing in the research of new treatments for opioid addiction. One of her experiments looks at how opioids may affect men and women differently.
“Previous studies have demonstrated that some opioid medications may be more effective and longer lasting in females, compared to males, but this effect has yet to be fully characterized in humans,” the Columbia University website reports.4 “Specifically, the effects of morphine, the prototypic agonist at the mu subtype of opioid receptor, and butorphanol, a mixed action opioid with effects at the kappa subtype of opioid receptor, are being studied.”
1.Omeros announces positive data from Phase 2 clinical trial evaluating PPAR-Gamma Agonist in Heroin Users Treated with Buprenorphine/Naloxone. (2016, Nov. 2). Business Wire. Retrieved Dec. 4, 2016, from http://investor.omeros.com/phoenix.zhtml?c=219263&p=irol-newsArticle_Print&ID=2218399
2.Tyagi S, et a. The peroxisome proliferator-activated receptor: A family of nuclear receptors role in various diseases. J Adv Pharm Technol Res 2011;2:236-40. Retrieved Dec. 4, 2016, from http://www.japtr.org/article.asp?issn=2231-4040;year=2011;volume=2;issue=4;spage=236;epage=240;aulast=Tyagi
3.OMS405. (2016, Nov. 15). Adis Insight. Retrieved Dec. 4, 2016, from http://adisinsight.springer.com/drugs/800035962
4.Sandra D. Comer, Ph.D. New York State Psychiatric Institute at Columbia University, Division on Substance Abuse. Retrieved Dec. 4, 2016, from http://surc.columbia.edu/comer.htm
Written by David Heitz