MIRA Pharmaceuticals Reports
MIRA Pharmaceuticals Reports New Topical Ketamir-2 shows comparable effects to Injected Morphine in Preclinical Pain Study
MIAMI, FLORIDA -- MIRA Pharmaceuticals, Inc., a clinical-stage pharmaceutical company focused on developing novel therapeutics for neurologic, neuropsychiatric, and metabolic disorders, today announced new preclinical data showing that its topical Ketamir-2 cream delivered similar and consistent pain relief compared with injected morphine in a validated animal model of acute and inflammatory pain.
In the study, Ketamir-2 cream was applied topically to the affected area 30 minutes before pain was induced using the formalin model, a widely accepted preclinical method for evaluating both acute and inflammatory pain. In this model, a small amount of formalin (a dilute formaldehyde solution) is injected into the paw, producing two well-characterized phases of pain: an initial acute phase driven by direct nerve activation, followed by a prolonged inflammatory phase associated with central sensitization (a mechanism shared with neuropathic pain). Researchers monitored spontaneous pain-related behaviors-specifically paw licking and paw lifting-using AI-assisted video analysis of 5-minute slots over a 60-minute period.
Topical Ketamir-2 was effective as Injected morphine in both phases, nearly eliminating pain behaviors during the acute phase and maintaining a strong, durable effect throughout the inflammatory phase. These results indicate Ketamir-2's potential to modulate both peripheral and central pain pathways with topical, localized delivery.
"These findings confirm Ketamir-2's potential as a next-generation, non-opioid topical treatment for localized pain," said Erez Aminov, Chairman and CEO of MIRA. "With our oral IND already cleared and a Phase 2a neuropathic pain trial expected to begin by year-end, this topical data meaningfully expands our clinical and commercial strategy. We're advancing a dual-route platform that can target both systemic and localized pain conditions-offering optionality for patients and value for shareholders."
Dual-Phase Pain Relief Without Systemic Burden
Unlike systemic analgesics, which circulate throughout the body and may cause unwanted side effects, Ketamir-2's topical formulation is designed to provide direct, localized pain relief with minimal systemic exposure. Its performance across both acute and inflammatory pain phases supports a broad therapeutic profile-potentially applicable to conditions such as diabetic neuropathy, chemotherapy-induced peripheral neuropathy (CIPN), postherpetic neuralgia, and osteoarthritis.
"What's remarkable is Ketamir-2's ability to nearly abolish acute pain behavior while also suppressing inflammation-driven responses," said Dr. Itzchak Angel, CSA at MIRA. "This dual-phase efficacy is rarely seen with topicals and strongly supports our rationale to continue advancing preclinical studies aimed at treating complex localized pain conditions."
Addressing an $11.5 Billion U.S. Topical Pain Market
The U.S. topical pain relief market is projected to exceed $11.5 billion by 2025, driven by demand for safer, non-opioid, non-systemic options, according to a report by Research and Markets. Chronic pain affects more than 51 million adults in the U.S., and many of the most prevalent pain conditions-such as osteoarthritis and neuropathy-are localized in nature.
