Vivozon said Tuesday that it has received approval from the Ministry of Food and Drug Safety (MFDS) for its phase 2 investigative new drug (IND) clinical trial for VVZ-2471, an oral, non-narcotic analgesic.

The phase 2 study will enroll 90 patients with postherpetic neuralgia at the Catholic University of Korea, Seoul St. Mary's Hospital, and Seoul National University Hospital. Patient enrollment will likely begin in the third quarter of this year.

Previously, Vivozon demonstrated the tolerability and safety of VVZ-2471 in a phase 1 study at Seoul National University Bundang Hospital (SNUBH).

As VVZ-2471 is an oral analgesic, Vivozon's strategy is to develop it to produce synergy with opiranserin (VVZ-149) developed as an injection. The multi-targeted, non-opioid analgesic opiranserin injection has completed the phase 3 trial by Vivozon’s affiliate, Vivozon Pharmaceutical. It is awaiting approval from the MFDS with the trade name Unafra Injection.

“As VVZ-2471 is a new drug that has been expanded and discovered based on the mechanism of action of opioids, we believe that it has a very high potential for clinical success,” Vivozon official said. “We will actively develop it as a broad-spectrum oral analgesic by adding a phase 2 study for central neuropathic and acute pain.”

Vivozon is also developing VVZ-2471 as a treatment for drug addiction or opioid addiction.

“VVZ-2471 has shown promise in nonclinical studies as a treatment for drug addiction,” the official said. “We are planning a phase 2 U.S. trial for the treatment of addiction to opioid analgesics and prevention of withdrawal symptoms, and will also explore its efficacy in alcoholism and nicotine addiction.”