The FDA has granted Fast Track designation to oliceridine (TRV130) for the management of moderate-to-severe acute pain, biopharmaceutical company, Tevena, announced this week.
The Fast Track program facilitates the development and clinical review of medicines intended to treat serious conditions with unmet medical needs by providing companies the ability to interact with the FDA on a frequent basis. The frequency of communication assures that questions and issues are resolved quickly, often leading to earlier drug approval and access by patients.
“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 for Trevena. “We look forward to working closely with the FDA to rapidly advance the development of oliceridine.”
Oliceridine (TRV130) was designed to deliver an improved analgesic profile. The drug activates analgesic signals, which suppress pain, while simultaneously avoiding the signals that can cause respiratory problems and constipation.
In August 2015, the company reported data comparing oliceridine to placebo and morphine following surgery, stating that “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.”
The company believes that oliceridine may offer “an improved safety and tolerability profile compared to currently used opioid analgesics while providing powerful pain relief to patients.”
The new drug will be used in acute care settings with a focus on moderate to severe acute pain in the hospital. Trevana hopes oliceridine will become a replacement for current intravenous opioid medications.
Phase 3 of the study is expected in early 2016.