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
MIRA Pharmaceuticals (NASDAQ:MIRA) has announced positive in vitro release testing (IVRT) results for its topical Ketamir-2 formulation, targeting the $11.5B U.S. topical pain relief market. The 5% ointment formulation demonstrated consistent and dose-proportional release in Franz diffusion cell model testing.
The company is advancing preclinical studies to evaluate the topical formulation for inflammatory and neuropathic pain conditions. The development aims to address chronic pain affecting 51.6 million U.S. adults, including osteoarthritis (32.5 million adults) and diabetic peripheral neuropathy (28% of diabetic adults).
MIRA is exploring FDA Fast Track designation possibilities and is simultaneously conducting a Phase 1 clinical trial of oral Ketamir-2 in healthy volunteers, with plans for a Phase 2a study in diabetic neuropathy.
MIRA Pharmaceuticals (NASDAQ:MIRA) ha annunciato risultati positivi nei test in vitro di rilascio (IVRT) per la sua formulazione topica Ketamir-2, rivolta al mercato statunitense del sollievo dal dolore topico da 11,5 miliardi di dollari. La pomata al 5% ha mostrato un rilascio costante e proporzionale alla dose nei test con il modello a cella di diffusione di Franz.
L'azienda sta portando avanti studi preclinici per valutare la formulazione topica nel trattamento del dolore infiammatorio e neuropatico. Lo sviluppo mira a rispondere al dolore cronico che colpisce 51,6 milioni di adulti negli Stati Uniti, inclusi 32,5 milioni con osteoartrite e il 28% degli adulti diabetici con neuropatia periferica.
MIRA sta valutando la possibilità di ottenere la designazione Fast Track dalla FDA e sta contemporaneamente conducendo uno studio clinico di Fase 1 sulla somministrazione orale di Ketamir-2 in volontari sani, con piani per uno studio di Fase 2a sulla neuropatia diabetica.
MIRA Pharmaceuticals (NASDAQ:MIRA) ha anunciado resultados positivos en pruebas de liberación in vitro (IVRT) para su formulación tópica Ketamir-2, dirigida al mercado estadounidense de alivio del dolor tópico de 11.5 mil millones de dólares. La pomada al 5% demostró una liberación constante y proporcional a la dosis en pruebas con el modelo de células de difusión de Franz.
La empresa está avanzando en estudios preclínicos para evaluar la formulación tópica en condiciones de dolor inflamatorio y neuropático. El desarrollo busca atender el dolor crónico que afecta a 51.6 millones de adultos en EE. UU., incluyendo 32.5 millones con osteoartritis y el 28% de adultos diabéticos con neuropatía periférica.
MIRA está explorando la posibilidad de obtener la designación Fast Track de la FDA y simultáneamente está llevando a cabo un ensayo clínico de Fase 1 con Ketamir-2 oral en voluntarios sanos, con planes para un estudio de Fase 2a en neuropatía diabética.
MIRA Pharmaceuticals (NASDAQ:MIRA)는 115억 달러 규모의 미국 국소 진통제 시장을 목표로 하는 국소용 Ketamir-2 제형의 시험관 내 방출 테스트(IVRT)에서 긍정적인 결과를 발표했습니다. 5% 연고 제형은 Franz 확산 세포 모델 테스트에서 일관되고 용량 비례적인 방출을 보여주었습니다.
회사는 염증성 및 신경병증성 통증 상태에 대한 국소 제형 평가를 위해 전임상 연구를 진행 중입니다. 이 개발은 골관절염(3,250만 명)과 당뇨병성 말초 신경병증(당뇨병 성인의 28%)을 포함해 미국 성인 5,160만 명에게 영향을 미치는 만성 통증 문제를 해결하는 것을 목표로 합니다.
MIRA는 FDA 패스트트랙 지정 가능성을 모색하고 있으며, 동시에 건강한 지원자를 대상으로 한 경구용 Ketamir-2 1상 임상시험을 진행 중이며, 당뇨병성 신경병증에 대한 2a상 연구도 계획하고 있습니다.
MIRA Pharmaceuticals (NASDAQ:MIRA) a annoncé des résultats positifs aux tests de libération in vitro (IVRT) pour sa formulation topique Ketamir-2, ciblant le marché américain des analgésiques topiques évalué à 11,5 milliards de dollars. La pommade à 5 % a démontré une libération constante et proportionnelle à la dose lors des tests avec le modèle de cellule de diffusion de Franz.
La société poursuit des études précliniques pour évaluer la formulation topique dans les douleurs inflammatoires et neuropathiques. Ce développement vise à répondre aux douleurs chroniques qui touchent 51,6 millions d’adultes aux États-Unis, dont 32,5 millions souffrant d’arthrose et 28 % des adultes diabétiques atteints de neuropathie périphérique.
MIRA explore la possibilité d’obtenir la désignation Fast Track de la FDA et mène simultanément un essai clinique de phase 1 avec Ketamir-2 oral chez des volontaires sains, avec des plans pour une étude de phase 2a dans la neuropathie diabétique.
MIRA Pharmaceuticals (NASDAQ:MIRA) hat positive Ergebnisse bei in vitro Freisetzungstests (IVRT) für seine topische Ketamir-2-Formulierung bekannt gegeben, die auf den 11,5 Milliarden Dollar schweren US-Markt für topische Schmerzmittel abzielt. Die 5%-Salbenformulierung zeigte in Tests mit dem Franz-Diffusionszellenmodell eine gleichmäßige und dosisproportionale Freisetzung.
Das Unternehmen treibt präklinische Studien voran, um die topische Formulierung bei entzündlichen und neuropathischen Schmerzbedingungen zu evaluieren. Die Entwicklung zielt darauf ab, chronische Schmerzen zu behandeln, die 51,6 Millionen US-Erwachsene betreffen, darunter 32,5 Millionen mit Osteoarthritis und 28 % der diabetischen Erwachsenen mit peripherer Neuropathie.
MIRA prüft die Möglichkeit einer Fast Track-Zulassung durch die FDA und führt gleichzeitig eine Phase-1-Studie mit oralem Ketamir-2 bei gesunden Freiwilligen durch, mit Plänen für eine Phase-2a-Studie bei diabetischer Neuropathie.
- Successful completion of in vitro release testing showing consistent and dose-proportional results
- Dual development strategy with both oral and topical formulations expanding market opportunities
- Targeting large $11.5B U.S. topical pain relief market
- Potential qualification for FDA Fast Track designation
- Still in early development stages with only in vitro data available
- Phase 1 trials not yet completed
- No clinical efficacy data available yet
Insights
Ketamir-2's topical formulation shows promising drug release characteristics in lab tests, but remains years from potential approval with significant hurdles ahead.
The in vitro release testing (IVRT) results for MIRA's topical Ketamir-2 represent an early but necessary milestone in pharmaceutical development. The 5% ointment formulation demonstrated two key technical characteristics: consistent release and dose-proportionality across multiple concentrations. This confirms the formulation's basic functionality - the drug can exit the delivery vehicle in a predictable manner.
From a technical perspective, IVRT using Franz diffusion cells primarily validates formulation mechanics rather than therapeutic efficacy. The stable compound performance in a hydrophobic base suggests appropriate formulation selection for a topical application, but doesn't predict clinical performance.
The development timeline remains extensive. MIRA is only now advancing to preclinical animal models for inflammatory and neuropathic pain - a stage that precedes any human testing. Should these animal studies show promise, the company would still need to complete Phase 1 safety studies, followed by Phase 2 efficacy trials, and Phase 3 confirmatory studies.
Their dual development strategy (oral and topical formulations) represents sound scientific risk distribution. The oral formulation has progressed further with Phase 1 trials underway and Phase 2a studies in diabetic neuropathy planned.
Dr. Angel's statement that Ketamir-2 may "surpass the demonstrated effects of Ketamine" in conditions like neuropathic pain and diabetic neuropathy represents a scientifically plausible hypothesis based on the compound's properties, but remains entirely theoretical until demonstrated in clinical studies.
While targeting an $11.5B pain market represents significant opportunity, MIRA's early-stage formulation faces a crowded landscape and lengthy development pathway.
MIRA's strategic focus on the topical pain relief market aligns with significant commercial opportunity. The projected $11.5 billion U.S. market by 2025 reflects growing demand for non-systemic and non-opioid alternatives amid continuing concerns about opioid dependence.
The company has identified substantial patient populations with clear unmet needs. The target indications - including neuropathic pain, diabetic neuropathy and musculoskeletal pain - affect millions of Americans. Diabetic peripheral neuropathy alone impacts approximately
MIRA's exploration of FDA Fast Track designation demonstrates regulatory pathway awareness. While neuropathic pain qualifies as a "serious condition" under FDA guidelines, securing such designation requires compelling preclinical evidence demonstrating substantial improvement over existing therapies - data that has yet to be generated.
The dual formulation approach (oral and topical) creates development optionality and potentially broader market access. This portfolio strategy helps mitigate development risk, particularly important given MIRA's relatively modest
However, the topical pain market is highly competitive with numerous established products across both prescription and OTC segments. The preliminary nature of current data means MIRA faces years of development work before potential commercialization, with significant technical, regulatory, and financial hurdles ahead. This in vitro milestone, while necessary, represents just one early step in a lengthy development process.
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
"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
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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