Depomed Acquires U.S. Rights to Late-Stage, First-in-Class Pain Product from Grunenthal
"Cebranopadol is a truly differentiated molecule with a novel dual mechanism-of-action, functioning as a high-potency agonist of both the mu-opioid and the nociceptin receptors. Cebranopadol's pharmacology is likely to confer analgesic efficacy equivalent to that of traditional opioids in peripherally-mediated, nociceptive pain conditions, while potentially conferring great efficacy in neuropathic pain and other pain states characterized by more centralized pain," said
Continued Dr. Rao: "These unique and beneficial properties, along with a strong scientific rationale and a robust clinical package, translate to a strong probability of success - making cebranopadol a great addition to our portfolio. Developmentally, we have a well-defined pathway to follow that we believe has the potential to add tremendous value to both the chronic pain armamentarium and the company."
"The acquisition of this novel compound with its unique structure and characteristics fits perfectly with our long-term commitment to expanding our leading pain management portfolio," said
Under the terms of the agreement,
To date, cebranopadol has been studied in sixteen Phase I, four Phase IIa and three Phase IIb trials in painful diabetic peripheral neuropathy (PDPN), osteoarthritis (OA) and chronic lower back pain as well as a human abuse potential study. In total, cebranopadol has been studied in approximately 2,000 patients worldwide. In summary, these studies confirm a profile of high potency and efficacy with good tolerability and the potential for a lower abuse profile.
"Cebranopadol is a first-in-class drug candidate due in large part to its unique ability to bind with high affinity to not only classical opioid receptors, but also the nociceptin/ orphanin FQ peptide, or NOP, receptors which may offer improved management of some pain states with decreased side effects. Indeed NOP agonists have been shown to have a broad range of effects, and balanced agonist activity at the NOP and mu receptors may result in an improved safety profile – reduced tolerance and reduced risk of respiratory depression versus mu agonist activity alone," said
Cebranopadol is a novel, first-in-class potent analgesic that has a dual mechanism-of-action as an agonist of both the nociceptin receptor (NOP) and the mu-opioid receptor (MOR). These mechanisms, which have been shown to synergize, result in both a comparable efficacy and broader analgesic spectrum versus standard mu-opioid receptor agonists as well as an improved safety profile, particularly as it pertains to dependence and respiratory depression. Cebranopadol has completed several Phase II trials in painful diabetic peripheral neuropathy (PDPN), osteoarthritis (OA) and chronic lower back pain (cLBP) and is ready for Phase III development.
NUCYNTA®, Gralise® CAMBIA®, Zipsor®, Lazanda® and Acuform® are registered trademarks of
"Safe Harbor" Statement under the Private Securities Litigation Reform Act of 1995. The statements that are not historical facts contained in this release are forward-looking statements that involve risks and uncertainties including, but not limited to, those related to the potential benefits of cebranopadol, the company's clinical development plans and expectations regarding cebranopadol and other risks detailed in the company's
VP, Investor Relations and Corporate Communications
Canale Communications for
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