Relmada And MSKCC Partner In Opioid Painkiller Studies
Clinical stage firm Relmada Therapeutics announced that it has partnered with Memorial Sloan Kettering Cancer Center (MSKCC) to launch several animal studies of levorphanol for chronic pain.
LevoCap ER is a once-a-day extended release dosage form of opioid analgesic levorphanol distributed in an abuse deterrent drug delivery system. Levorphanol differs from other painkillers as it modulates pain via both the ascending opioidergic pathways and descending noradrenergic pathways in a single centrally-acting analgesic.
Under the terms of the agreement, the partners will conduct a series of animal studies to further characterize levorphanol’s mechanism of action at the molecular and behavioral levels based on current knowledge of opioid mechanisms. The studies will aim to differentiate the drug from morphine and other traditional opioid analgesics. The study’s investigators will also attempt to determine whether the drug’s actions involve a new subset of mu opioid receptor splice variants.
Eliseo Salinas, President and CSO of Relmada Therapeutics, said, “Unlike oxycodone, morphine, hydromorphone, oxymorphone, and hydrocodone, levorphanol seems to modulate pain through mechanisms common with those traditional opioids (the ascending opioid pathways) as well as a unique combination of mechanisms involving delta, kappa, and N-methyl-D-aspartate (NMDA) receptors, the norepinephrine and serotonin transporters, as well as different variant of the mu opioid receptor described by Pasternak’s group. This unique combination of mechanisms may explain its efficacy and its ability to partially reverse tolerance to morphine.”
Sergio Traversa, CEO of Relmada Therapeutics, stated that MSKCC’s background on pain mechanisms complements the company’s research focus. “Relmada is delighted to work with Dr. Pasternak and his team at Memorial Sloan Kettering… We are confident that new treatments for pain are needed, and we believe that levorphanol’s promise is worth the greatest consideration.”
The FDA has reaped criticism for previous painkiller approvals, including Zogenix’s Zohydro ER. Earlier this month, U.S. governors wrote to the Health and Human Services Secretary Sylvia Burwell persuading her to override the agency’s approval for the drug. The FDA stood by its decision and has approved another powerful painkiller with similar abuse-deterrent properties. Purdue Pharma’s Targiniq ER, a combination of narcotic oxycodone and naloxone for chronic pain, was approved by the FDA this July.