- MIRA Pharmaceuticals (NASDAQ:MIRA) releases positive in vitro results for its Ketamir-2 topical formulation targeting the $11.5 billion U.S. pain relief market.
- The 5% Ketamir-2 ointment demonstrated consistent, dose-proportional release in Franz diffusion cell model testing.
- MIRA aims to secure FDA Fast Track designation, advancing toward preclinical and clinical trials for both topical and oral formulations.
MIRA Pharmaceuticals, Inc. (NASDAQ:MIRA), a clinical-stage pharmaceutical company, announced positive in vitro release testing (IVRT) results for its topical Ketamir-2 ointment formulation. The development is a significant step as MIRA targets the expansive $11.5 billion U.S. topical pain relief market. The 5% ointment formulation demonstrated consistent and dose-proportional release in Franz diffusion cell model testing, marking a critical milestone in the formulation's development.
The company's ongoing work includes advancing preclinical studies to evaluate the topical formulation for treatment in inflammatory and neuropathic pain conditions. This initiative aims to address chronic pain, which affects 51.6 million U.S. adults, including osteoarthritis (32.5 million adults) and diabetic peripheral neuropathy affecting 28% of diabetic adults.
As part of its regulatory strategy, MIRA is exploring the possibility of obtaining the FDA's Fast Track designation for Ketamir-2. This designation can expedite the development and review process, addressing serious conditions with unmet medical needs. Furthermore, MIRA is conducting a Phase 1 clinical trial for an oral formulation of Ketamir-2, with plans for a Phase 2a study focusing on diabetic neuropathy.
MIRA's dual development strategy, which includes both oral and topical formulations, provides significant market opportunities and positions the company to address a broader segment of the pain relief market. This strategy not only enhances market access but also mitigates development risks, offering potential benefits across multiple pain-related conditions.
