Pain Medication Given FDA Breakthrough Tag

(DARPA.gov)

22 February 2016. A new drug to treat moderate to severe pain, now in clinical trials, received a breakthrough designation from the U.S. Food and Drug Administration. The drug, oliceridine, is made by Trevena Inc. in King of Prussia, Pennsylvania.

Oliceridine addresses the same pain signals as opioid drugs that affect areas of the brain recognizing pain, but uses a different mechanism, which reduces many of the adverse effects associated with opioid pain relievers. The drug targets a signaling pathway associated with ligands, or binding molecules, to pain-recognition regions of the brain affected by opioid pain relievers, while avoiding other pathways that promote respiratory and gastrointestinal distress often encountered when taking opioids.

Trevena’s technology is based on research at Duke University on G protein-coupled receptor signaling by medical school researchers Robert Lefkowitz — a winner of the 2012 Nobel Prize in chemistry — and Howard Rockman. G protein-coupled receptors are found on cell surfaces and are the targets for as many as half of current prescription drugs including antihistamines, ulcer drugs, and beta blockers to treat heart conditions. Trevena was founded by three postdoctoral researchers in Lefkowitz’s lab, and Lefkowitz and Rockman serve as scientific advisers to the company.

That broad coverage, however, creates a down side for addressing G protein-coupled receptors, namely unwanted side effects that can negate many of a drug’s benefits. Trevena’s technology addresses more specified pathways, called biased ligands, that can more precisely target receptors on cell surfaces, in this case opioid pain receptors, and avoid affecting other pathways causing adverse effects.

Oliceridine is Trevena’s lead product, tested in 6 completed and 2 current clinical trials. The company is developing oliceridine as an intravenous drug, prescribed to treat post-surgical pain. In intermediate-stage trials, says Trevena, patients taking oliceridine experienced rapid pain relief, without the nausea, vomiting, or low breathing rates often associated with morphine. The company is currently recruiting participants for a late-stage trial to test oliceridine as a treatment for acute pain from surgery or other medical conditions, and an intermediate-stage trial testing the drug to treat fracture pain.

FDA assigns a breakthrough designation to therapies that address a serious condition and demonstrate through clinical evidence that the treatment is a substantial improvement over current methods. Once designated as a breakthrough therapy, a drug or biologic can receive early and frequent communications with FDA staff, quick resolution of questions, intensive guidance on drug development, and an organizational commitment from top managers.

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