The United States Food and Drug Administration (FDA) has granted Fast Track designation to Trevena's oliceridine (TRV130) for the management of moderate-to-severe acute pain. Oliceridine is being developed as a potential replacement for currently approved intravenous opioid analgesics.
In a recently completed phase 2 study in postoperative pain, oliceridine matched the analgesic efficacy of morphine with an improved safety and tolerability profile. Trevena expects to initiate phase 3 development of oliceridine in the first quarter of 2016.
“We believe that this fast track designation represents recognition by FDA of the significant unmet needs in the management of acute pain and of the potential for oliceridine to improve on current standards of care,” stated Maxine Gowen, Ph.D., chief executive officer. “We look forward to working closely with the FDA to rapidly advance the development of oliceridine.”
The Fast Track programme, established under the FDA Modernization Act of 1997, is designed to facilitate the development and review of drugs intended to treat serious conditions with unmet medical needs by providing sponsors with the opportunity for frequent interactions with the FDA.
Mu opioid receptor agonists such as morphine and fentanyl are the most effective class of analgesics currently available and are the standard of care in moderate to severe acute pain; however, in published national surveys, a significant proportion of surgical patients have reported inadequate pain relief despite use of opioid analgesics. Opioid-related adverse effects such as respiratory depression, nausea and vomiting, are frequently dose-limiting, which complicates Pain management and increases the burden of care.
Oliceridine (TRV130) was designed to optimise opioid receptor pharmacology to deliver an improved analgesic profile. Oliceridine is a biased mu-opioid receptor ligand that in preclinical studies activated analgesic signals while avoiding signals that can interfere with analgesia and promote respiratory depression and gastrointestinal dysfunction. In August 2015, Trevena reported data from a phase 2b trial comparing oliceridine to placebo and morphine following abdominoplasty surgery using on-demand patient-controlled analgesia. In that trial, oliceridine demonstrated comparable efficacy to a standard regimen of morphine, with a significantly lower incidence of nausea, vomiting, and hypoventilation – a measure of respiratory safety. In previous clinical trials, oliceridine delivered profound levels of pain relief safely and rapidly compared to IV morphine, and doses of oliceridine that were more effective than morphine simultaneously depressed respiratory drive to a lesser degree than morphine.
Trevena believes that oliceridine may offer an improved safety and tolerability profile compared to currently used opioid analgesics while providing powerful pain relief to patients. Trevena anticipates that the initial market opportunity for oliceridine will be in the acute care settings, with a focus on moderate to severe acute pain in the hospital.
