Mebias' mu opioids best morphine, Trevena drug in preclinical studies

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The FDA's action plan against opioid abuse includes convening an advisory committee before approving a new drug application for an opioid, strengthening postmarket requirements and developing better labeling.

There was a time that opioids were used only to treat pain associated with injury, surgery or cancer. But the use of the powerful painkillers to treat chronic, noncancer pain has skyrocketed in recent years, the CDC says, leading to drug abuse and the current opioid epidemic.

Mebias Discovery is one company working on a solution. Mebias presented preclinical data at the Academic Drug Discovery Consortium for a pair of mu opioid agonists which are designed to relieve pain without the harmful side effects that come with opioids. Regular use of opioids can lead not only to dependence, overdose and death, but also to other side effects, such as constipation, nausea and sleepiness.

The studies were conducted in rats and pitted Mebias’ mu opioids, dubbed MEB-1166 and MEB-1170, against morphine and Trevena’s mu opioid, oliceridine. The data showed that Mebias’ compounds did not cause respiratory depression, slow or ineffective breathing, even at high doses, while both morphine and oliceridine did.

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The results also showed that both candidates alleviated pain without causing sleepiness or constipation. A study looking at addiction potential found that MEB-1170 “induced no reward or liking behavior,” according to the company. Mebias plans to bring these candidates into clinical development and to partner with other biopharma players in the future.

The number of opioids prescribed and sold in the U.S. has quadrupled since 1999. In 2015 alone, 12.5 million people misused prescription opioids, with 2.1 million of them misusing the drugs for the first time, according to Department of Health and Human Services statistics. There were more than 15,000 deaths pegged to overdosing on commonly prescribed opioids, surpassing the nearly 13,000 deaths from heroin overdose.

The FDA has devised an action plan, among other measures, to tackle the opioid crisis, and President Donald Trump is said to be on the cusp of declaring it a national emergency. The FDA recently approved Pear Therapeutics’ mobile app to treat substance abuse, as well as Braeburn Pharmaceuticals’ buprenorphine-delivering implant intended to curb illicit opioid use. Meanwhile, medtech mainstays Medtronic and Abbott market spinal cord stimulation systems, which are drug-free alternatives for chronic pain.

Mebias will be entering an increasingly crowded competition to develop safer pain remedies. Trevena is betting it big on oliceridine. In fact, the company is slashing one-third of its staff, halting investment in early-stage R&D and dumping its heart failure drug to focus on the injectable pain drug. And Nektar Therapeutics’ own mu opioid for chronic pain beat out placebo in improving pain scores with low rates of nausea and constipation.