FDA Grants Non-Opioid Analgesic VVZ-149 Fast Track Status
The Food and Drug Administration (FDA) has fast-tracked VVZ-149 (Vivozon Inc), a non-opioid, non-NSAID analgesic for the treatment of pain.
According to Vivozon, in vivo tests have shown that the compound's pain suppressing efficacy is comparable to morphine. A Phase 2b clinical trial of VVZ-149 is ongoing in centers in Korea and the US. The trial is investigating the compound as an IV infusion treatment for postoperative pain following laparoscopic gastrectomy or laparoscopic colorectomy and lumbar radiculopathy. They are also investigating the potential for an oral formulation.
Vivozon worked with the research organization MMS holdings to devise their regulatory strategy. "I am pleased that we were able to attain this Fast Track status and look forward to working with MMS as we continue into the Phase 3 studies," said CEO and Head Researcher at Vivozon, Dr Doo Lee.
For more information visit Vivozon.com.