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MIRA Pharmaceuticals Designates Neuropathic Pain as Primary Indication for Ketamir-2 and Submits Pre-IND Meeting Request to FDA
MIAMI, FL / ACCESSWIRE / September 11, 2024 / MIRA Pharmaceuticals, Inc. (NASDAQ:MIRA), a preclinical-stage pharmaceutical company focused on developing
About this update from Mira Pharmaceuticals, Inc.
[{"type":"text","content":"MIAMI, FL / ACCESSWIRE / September 11, 2024 / MIRA Pharmaceuticals, Inc. (NASDAQ:MIRA), a preclinical-stage pharmaceutical company focused on developing innovative therapies for neurologic and neuropsychiatric disorders, announced today that it has selected neuropathic pain as the initial and primary indication for its novel oral ketamine analog, Ketamir-2. The company has submitted a request for a pre-Investigational New Drug (IND) meeting with the U.S. Food and Drug Administration (FDA) and anticipates the meeting to occur in November 2024. All ongoing regulatory IND-enabling studies are advancing smoothly, and MIRA remains on track to submit its IND to the FDA by the end of this year, with human trials expected to begin in the first quarter of 2025.The Growing Neuropathic Pain MarketNeuropathic pain is a complex and debilitating condition caused by a variety of causes, induced by damage or dysfunction of the nervous system. It often presents as burning, electric shocks, or \"pins and needles\" sensations, significantly impacting the quality of life for millions of patients. The North American market for neuropathic pain treatments is projected to grow to approximately $5.2 billion across the U.S., Canada, and Mexico by 2030, driven by rising prevalence rates, an aging population, and the increasing burden of diseases such as diabetes and chemotherapy-induced neuropathy (Databridgemarketresearch.com).Current treatment options for neuropathic pain, including antidepressants, anticonvulsants, topical agents, and opioids, often provide limited relief and include significant side effects. For example, antidepressants and anticonvulsants can cause dizziness, weight gain, and sedation, while opioids carry risks of addiction, tolerance, and withdrawal. The opioid crisis alone is costing the United States approximately $1 trillion annually, a stark reminder of the devastating consequences of opioid misuse, recently underscored by the tragic death of actor Matthew Perry, who had openly struggled with addiction (Congressman David Trone).Ketamir-2: Positioned to Transform Neuropathic Pain ManagementKetamir-2 is MIRA's response to this pressing market need-a novel ketamine analog designed to enhance therapeutic efficacy, improve oral bioavailability, and offer a superior safety profile compared to existing treatments. Unlike traditional k...