OMS405 reduces cravings, anxiety in heroin addiction

Phase 2 study findings indicated a peroxisome proliferator-activated receptor-gamma agonist, OMS405 from Omeros, reduced heroin cravings and anxiety in individuals with heroin dependence.

“Development of pharmacological strategies aimed at improving opioid-based treatments of heroin addiction is a major clinical need,” study researcher Sandra Comer, PhD, of Columbia University and New York State Psychiatric Institute, said in a press release. “The data with the [peroxisome proliferator-activated receptor]-gamma agonist are encouraging and suggest that it has therapeutic potential for opioid use disorder.”

To assess efficacy of OMS405, researchers conducted a double-blind, placebo-controlled clinical trial among 30 heroin users who were not seeking treatment and were admitted to an inpatient unit. Study participants were randomly assigned to receive OMS405 (n = 14) or placebo (n = 16) daily for up to 3 weeks. All study participants were maintained on 8 mg/2 mg of buprenorphine/naloxone.

Analysis indicated a statistically significant reduction in heroin craving among participants who received OMS405, compared with placebo.

OMS405 also reduced anxiety; however, no effect on heroin self-administration or heroin-induced positive subjective effects were found.

These findings are consistent with previous findings among individuals with cocaine dependence who received 12 weeks of treatment with a peroxisome proliferator-activated receptor-gamma agonist.

Adverse effects were minimal and similar in both studies, according to researchers.

“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 of in excess of $1.1 billion,” Gregory A. Demopulos MD, chairman and CEO of Omeros, said in the release. “Heroin abuse affects over 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.”

Omeros reported it has issued and pending patents in OMS405 for the use off any peroxisome proliferator-activated receptor-gamma agonist alone or in conjunction with other addiction treatments to treat all addictions and substance use disorders.