[Public Notice+] Medipron Receives MFDS IND Approval for Phase 1 Clinical Trial of Non-Opioid Analgesic

[Asia Economy Reporter Hyunseok Yoo] Mediphron Divity, a company specializing in innovative drug development, announced on the 12th that it has received approval from the Ministry of Food and Drug Safety (MFDS) for the clinical phase 1 trial plan (IND) of a topical non-narcotic analgesic (1% MDR-652gel).

'1% MDR-652gel' is a topical non-narcotic analgesic that acts as an agonist of the vanilloid receptor (TRPV1). It is a new drug substance secured through joint research with the U.S. National Institutes of Health (NIH). It is expected to suppress various neuropathic pains such as diabetic neuropathic pain, postherpetic neuralgia, postoperative pain, and cancer pain, which do not respond to general anti-inflammatory analgesics.

This clinical trial will be conducted at Seoul St. Mary's Hospital using a randomized, placebo-controlled, double-blind, maximum usage evaluation method to assess the safety, tolerability, and systemic exposure characteristics after single and repeated transdermal administration of 1% MDR-652gel.

Narcotic analgesics (opioids) are drugs used to manage severe pain such as chronic neuropathic pain and postoperative pain that cannot be relieved by anti-inflammatory analgesics or nonsteroidal analgesics. However, due to concerns about addiction, the U.S. government recommends reducing opioid prescriptions, and there is a need to develop non-narcotic analgesics that can replace opioids.

According to a report by the U.S. Centers for Disease Control and Prevention (CDC), among 702,000 deaths caused by drug overdose from 1999 to 2017, 470,000 (68%) were related to opioid overdose. It is known that an average of 115 Americans die daily from opioid overdose.

Youngdong Yoo, head of the Mediphron Research Institute, said, "1% MDR-652gel has secured strong analgesic efficacy and safety through nonclinical trials and can be applied to various neuropathic pains," adding, "A path has opened to simultaneously address chronic pain treatment and the misuse of narcotic analgesics."

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