Ketamir-2 from MIRA Pharmaceuticals Raises the Bar in Pain Management, Outshining FDA-Approved Treatments

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The world of pain management may be on the brink of significant change. MIRA Pharmaceuticals (MIRA)  has unveiled preclinical data showing that its new drug, Ketamir-2, significantly outperforms two leading FDA-approved treatments—Gabapentin (Neurontin) and Pregabalin (Lyrica). With the potential to deliver safer and more effective results, Ketamir-2 could soon shift the landscape for millions of patients struggling with chronic pain.

 Neuropathic pain, a complex and often debilitating condition, is commonly treated with Gabapentin and Pregabalin. However, these medications bring with them side effects—such as drowsiness, dizziness, cognitive impairment, and dependence—which can undermine their long-term effectiveness. Despite these challenges, the market for Gabapentin is expected to reach $4.95 billion by 2033, with Pregabalin projected to grow to $2.2 billion by 2032. 

MIRA’s Ketamir-2 offers a new path forward, showing impressive results in preclinical trials. In a nerve ligation-induced neuropathy model, Ketamir-2 provided 112% more pain relief than Pregabalin and 70% greater relief than Gabapentin by Day 22. Notably, in earlier trials involving male rats, Ketamir-2 fully reversed neuropathic pain—a result that oral ketamine failed to achieve. 

A Non-Opioid Solution That Stands Out 

What sets Ketamir-2 apart is more than just its superior efficacy. Unlike other pain medications, Ketamir-2 is a non-opioid and non-controlled substance, reducing the risk of addiction—a key concern in today’s healthcare landscape. With a safer profile, it presents an appealing alternative to existing treatments that carry the burden of side effects and dependency risks. 

MIRA Pharmaceuticals believes that this breakthrough could offer renewed hope to patients who struggle with current medications. “Ketamir-2 has shown remarkable potential to change how chronic pain is treated,” said Erez Aminov, Chairman and CEO of MIRA Pharmaceuticals. “This drug could offer patients a safer, more effective way to manage their pain without compromising their quality of life.” 

Beyond Pain: Unlocking New Potential 

Ketamir-2’s benefits may go beyond treating neuropathic pain. MIRA is gearing up to test the drug’s potential in addressing post-traumatic stress disorder (PTSD), where there is a growing need for non-addictive alternatives. The company is actively exploring government funding opportunities to support these efforts, aiming to demonstrate the drug’s value in mental health treatment. 

Accelerating Progress: What’s Next for MIRA 

With the release of these preclinical results, MIRA Pharmaceuticals is moving swiftly toward clinical development. The company plans to submit its Investigational New Drug (IND) application by the end of 2024, with Phase 1 trials set to begin in early

2025. If the trials progress as planned, Phase 2 trials could follow by the end of 2025, providing the first glimpse of human efficacy within a year. 

Dr. Angel, Chief Scientific Advisor at MIRA, expressed optimism about the road ahead: “The progress we’ve made so far is inspiring. We’re focused on advancing Ketamir-2 through clinical trials and making this innovative treatment available to patients as soon as possible.” 

Opportunities on the Horizon 

For investors, MIRA Pharmaceuticals presents a unique opportunity. With a current market cap of $17.079 million, the company's valuation might not fully reflect its potential worth when compared to its peers in the biotech space. As it progresses through clinical trials, MIRA’s innovative approach to pain and mental health treatment positions it for substantial growth. 

With Ketamir-2 showing superior efficacy and fewer risks compared to established drugs, MIRA Pharmaceuticals is poised to make a lasting impact. As the company advances toward human trials, it offers both hope for patients and opportunities for investors, signaling that the next breakthrough in pain management may already be within reach.

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