MIRA Pharmaceuticals Reports Positive In Vitro Drug Release Data for Topical Ketamir-2, Targeting $11B+ U.S. Topical Pain Relief Market and Exploring FDA Fast Track Designation

April 23, 2025 at 08:00 AM EDT

MIAMI, FLORIDA / ACCESS Newswire / April 23, 2025 / MIRA Pharmaceuticals, Inc. (NASDAQ: MIRA), or MIRA, a clinical-stage pharmaceutical company focused on developing novel therapeutics for neurologic and neuropsychiatric disorders, today announced the completion of in vitro release testing (IVRT) for its topical formulation of Ketamir-2. The formulation is under investigation for localized application in pain-related conditions.

The IVRT study assessed a 5% ointment formulation of Ketamir-2 using a validated Franz diffusion cell model. The formulation demonstrated consistent and dose-proportional release across multiple concentrations. The active compound remained stable within a hydrophobic base, and testing parameters followed FDA-recommended guidance for topical product evaluation.

"As we continue expanding the Ketamir-2 program, we remain committed to building long-term shareholder value through strategic innovation and disciplined execution," said Erez Aminov, Chairman and CEO of MIRA. "The ability to develop both oral and a localized topical formulation positions us to address a much broader segment of the pain market, which represents a significant commercial opportunity and a clear path for differentiation in a space that urgently needs safer, more targeted treatment options."

MIRA is currently advancing preclinical studies to evaluate the topical formulation in models of inflammatory and neuropathic pain. The goal of these studies is to further characterize in vivo performance and inform potential clinical development strategies.

"We are encouraged by the consistency of the release profile under controlled conditions," said Dr. Itzchak Angel, Chief Scientific Advisor at MIRA. "Our focus now shifts to evaluating pharmacological effects in preclinical models to guide next steps. We expect this development to surpass the demonstrated effects of Ketamine in localized pain, such as in neuropathic, diabetic neuropathy, postherpetic neuralgia or musculoskeletal pain, as it also may decrease inflammation and central sensitization."

Addressing a Pressing Need and Expanding Market Opportunity

Chronic pain remains a widespread issue in the United States, affecting an estimated 51.6 million adults, with nearly one-third experiencing high-impact pain that limits daily activity. Localized inflammatory and neuropathic conditions are key contributors, with osteoarthritis affecting more than 32.5 million adults and diabetic peripheral neuropathy impacting approximately 28% of adults with diabetes. These conditions represent a significant segment of the broader pain management landscape. The U.S. topical pain relief market alone is projected to exceed $11.5 billion by 2025, reflecting increased interest in non-systemic and non-opioid treatment alternatives.

Regulatory Pathway Considerations

The FDA has identified neuropathic pain as a serious condition for which expedited development programs-such as Fast Track and Breakthrough Therapy designation-may be applicable when supported by qualifying data. MIRA is evaluating whether the topical Ketamir-2 formulation may meet the requirements for such a designation as the program advances.
(See: FDA Guidance for Industry - Expedited Programs for Serious Conditions)

Multi-Route Development Strategy

In addition to the topical formulation, MIRA is currently conducting a Phase 1 clinical trial of oral Ketamir-2 in healthy volunteers. A Phase 2a study in diabetic neuropathy is planned to follow. Developing both systemic and localized formulations may provide greater optionality in addressing a range of pain-related conditions.

About MIRA Pharmaceuticals, Inc.

MIRA Pharmaceuticals, Inc. (NASDAQ: MIRA) is a clinical-stage pharmaceutical development company with two neuroscience programs targeting a broad range of neurologic and neuropsychiatric disorders. MIRA holds the exclusive U.S., Canadian, and Mexican rights for Ketamir-2, a novel, patent-pending oral ketamine analog under investigation to treat neuropathic pain (NP), treatment-resistant depression (TRD), major depressive disorder with suicidal ideation (MDD-SI), and post-traumatic stress disorder (PTSD).

MIRA's novel oral pharmaceutical marijuana analog, MIRA-55, is currently under investigation for treating adult patients suffering from anxiety and cognitive decline, often associated with early-stage dementia. If approved by the FDA, MIRA-55 could mark a significant advancement in addressing various neuropsychiatric, inflammatory, and neurologic diseases and disorders.

The U.S. Drug Enforcement Administration's scientific review concluded that both Ketamir-2 and MIRA-55 would not be considered controlled substances or listed chemicals under the Controlled Substances Act and its governing regulations.

Additional information about MIRA Pharmaceuticals is available at www.mirapharmaceuticals.com.

Cautionary Note Regarding Forward-Looking Statements

This press release and the statements of MIRA's management related thereto contain "forward-looking statements," which are statements other than historical facts made pursuant to the safe harbor provisions of Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended. These statements may be identified by words such as "aims," "anticipates," "believes," "could," "estimates," "expects," "forecasts," "goal," "intends," "may," "plans," "possible," "potential," "seeks," "will," and variations of these words or similar expressions that are intended to identify forward-looking statements. Any statements in this press release that are not historical facts may be deemed forward-looking. Any forward-looking statements in this press release are based on MIRA's current expectations, estimates, and projections only as of the date of this release and are subject to a number of risks and uncertainties (many of which are beyond MIRA's control) that could cause actual results to differ materially and adversely from those set forth in or implied by such forward-looking statements, including related to MIRA's potential merger with SKNY Pharmaceuticals, Inc. These and other risks concerning MIRA's programs and operations are described in additional detail in the Annual Report on Form 10-K for the year ended December 31, 2024, and other SEC filings, which are on file with the SEC at www.sec.gov and MIRA's website at https://www.mirapharmaceuticals.com/investors/sec-filings. MIRA explicitly disclaims any obligation to update any forward-looking statements except to the extent required by law.

Contact Information

Helga Moya
info@mirapharma.com
(786) 432-9792

SOURCE: MIRA Pharmaceuticals

View the original press release on ACCESS Newswire

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MIRA Pharmaceuticals Reports Positive In Vitro Drug Release Data for Topical Ketamir-2, Targeting $11B+ U.S. Topical Pain Relief Market and Exploring FDA Fast Track Designation

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