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Investigational Intranasal Ketamine for PTSD

FTR-101 nasal spray is an investigational formulation of ketamine which optimized absorption through the nasal mucosa by incorporating a proprietary excipient, Intravail® (Neurelis, Inc)

Ketamine, a racemic mixture of r and s-ketamine is a non-barbiturate, non-competitive N-methyl-D-aspartate (NMDA) receptor antagonist. In clinical trials of ketamine administered intravenously, subjects showed improvement from baseline in symptoms of posttraumatic stress disorder (PTSD) at doses that were generally found to be safe and well tolerated.1,2

The Icahn School of Medicine at Mount Sinai, which has led groundbreaking research for ketamine in this area of high unmet need, has partnered with Frontier to develop intranasal ketamine for PTSD.

About Post-traumatic Stress Disorder (PTSD)

PTSD is a chronic debilitating psychiatric disorder arising after exposure to a severe traumatic stressor (e.g., combat, assault, accident) and is one of the most common mental health disorders in the United States, with lifetime prevalence estimated at approximately 8% of the general population3.

1 Feder, A., Parides, M. K., Murrough, J. W., et al. (2014). Efficacy of Intravenous Ketamine for Treatment of Chronic Posttraumatic Stress Disorder: A Randomized Clinical Trial. JAMA Psychiatry, 71(6), 681-688. doi:10.1001/jamapsychiatry.2014.62.
2 Feder, A., Costi, S., Rutter, S. B., et al. (2021). A Randomized Controlled Trial of Repeated Ketamine Administration in PTSD. American Journal of Psychiatry, 178(2), 193-202. doi:10.1176/appi.ajp.2020.20050596.
3 Committee on the Assessment of Ongoing Effects in the Treatment of Posttraumatic Stress Disorder; Institute of Medicine. Treatment for Posttraumatic Stress Disorder in Military and Veteran Populations: Initial Assessment. Washington (DC): National Academies Press (US); 2012 Jul 13. 2, History, Diagnostic Criteria, and Epidemiology.

News

  • Frontier Pharma Enters into a Worldwide Intellectual Property Licensing Agreement to Develop and Commercialize Intranasal Ketamine for Post Traumatic Stress Disorder (PTSD) with the Icahn School of Medicine at Mount Sinai

    • Lake Forest, IL and New York, NY - May 27, 2025 - Frontier Pharma LLC of Lake Forest, IL ("Frontier") today announced a joint venture and exclusive intellectual property licensing agreement that include worldwide granted and pending patents for PTSD. Frontier Pharma LLC is a specialty pharmaceutical company formed by entrepreneur Michael Burke to further develop an existing proprietary formulation of intranasal ketamine for the treatment of PTSD.

    PTSD is a chronic debilitating psychiatric disorder arising after exposure to a severe traumatic stressor (e.g., combat, assault, accident) and is one of the most common mental health disorders in the United States. According to the National Academy of Medicine, the lifetime prevalence is estimated at approximately 8% of the general population. Researchers at Mount Sinai have successfully completed two randomized, controlled clinical studies demonstrating that NMDA receptor modulation with ketamine leads to rapid clinical improvement of core PTSD symptoms.

    Erik Lium, PhD, Chief Commercial Innovation Officer at the Mount Sinai Health System and President of Mount Sinai Innovation Partners, said, "These discoveries supported the development of a robust intellectual property portfolio that has been licensed to Frontier Pharma. We are excited to partner with the Frontier Pharma team to further advance the development of ketamine for the treatment of PTSD."

    The CEO and Manager of Frontier, Michael Burke said "I'm very pleased to launch Frontier Pharma and to work with the Icahn School of Medicine at Mount Sinai. Frontier Pharma is starting with a fully developed investigational formulation of intranasal ketamine which has been evaluated in two completed phase I pharmacokinetic, safety and tolerability studies. We are very excited to bring our high bioavailability intranasal ketamine investigational product to a mental health category with very high unmet need."

    The agreement and patents licensed by the Icahn School of Medicine to Frontier builds on more than a decade of work from Mount Sinai researchers Drs. Dennis Charney and Adriana Feder - key opinion leaders in the field of ketamine research, trauma and mood disorders. Their research has informed the treatment landscape and has opened the door to entirely new approaches to addressing trauma-related conditions.

    As part of the agreement, the Icahn School of Medicine will become a minority shareholder of Frontier, and Mount Sinai scientists will consult for the planning and execution of Frontier's intranasal ketamine development program together with experts from Massachusetts General Hospital in Boston.

    Frontier's intranasal ketamine formulation incorporates the excipient Intravail®, which enables rapid uptake through the nasal mucosa. Data from two Phase 1 pharmacokinetic studies conducted outside the U.S. demonstrated sufficient exposures of the investigational formulation to support a planned PTSD development program. Intravail® is a proprietary permeation enhancer currently utilized in four FDA approved drugs. Frontier has exclusively licensed Intravail® for use in ketamine product formulations from Aegis Therapeutics, LLC (a Neurelis, Inc. affiliate).

    Frontier Pharma LLC, is a controlled affiliate of the MMB Healthcare Group, headquartered in Lake Forest IL. Frontier and the Icahn School of Medicine at Mount Sinai have partnered in a joint venture to develop intranasal ketamine for PTSD, expanding on research and discoveries developed at Mount Sinai.