FAQ: NRx Pharmaceuticals' Two-Pronged Approach to Ketamine-Based Therapies

What is NRx Pharmaceuticals’ two-pronged approach to bringing ketamine therapies to market?

NRx is pursuing two separate regulatory pathways: an Abbreviated New Drug Application (ANDA) for KETAFREE™ for all currently approved ketamine indications, and a New Drug Application (NDA) for NRX-100 specifically for the treatment of suicidal depression, including bipolar depression.

Why is NRx developing preservative-free ketamine formulations?

Current ketamine formulations often contain benzethonium chloride (BZT), a preservative associated with cytotoxic and neurotoxic effects that is no longer considered Generally Recognized as Safe and Effective for pharmaceutical use, prompting the development of safer alternatives.

What regulatory progress has NRx made with KETAFREE™?

The company recently refiled an ANDA for KETAFREE™ following FDA approval of its Suitability Petition to eliminate BZT from ketamine formulations, positioning it as a safer, fully compliant version for hospital and outpatient use.

What advantages does NRX-100 have in the regulatory process?

NRX-100 has been granted Fast Track Designation by the FDA for the treatment of suicidal depression, positioning it for potential expedited review and faster market access for patients with acute suicidality.

What other therapeutic areas is NRx Pharmaceuticals developing treatments for?

Beyond ketamine therapies, NRx is developing NRX-101 as an FDA-designated Breakthrough Therapy for suicidal treatment-resistant bipolar depression and chronic pain, with potential applications for PTSD and complicated UTI treatment.

How does NRx’s approach address current healthcare challenges?

The company aims to provide safer ketamine formulations at a time when supply constraints and rising demand have challenged healthcare providers, offering compliant alternatives to existing formulations with safety concerns.

What is the significance of the FDA removing BZT from pharmaceutical use?

The FDA has removed BZT from topical antiseptics and hand cleansers over safety concerns, and the European Medicines Agency has discouraged its use in injectable drugs, validating NRx’s focus on preservative-free formulations.

Where can investors find the latest updates about NRx Pharmaceuticals?

The latest news and updates relating to NRXP are available in the company’s newsroom at https://ibn.fm/NRXP.

What clinical evidence supports NRx’s NDA filing for NRX-100?

The NDA filing for NRX-100 is based on results from well-controlled clinical trials conducted by the U.S. National Institutes of Health and newly obtained data from French health authorities licensed under a data sharing agreement.

How does NRx plan to advance NRX-101 through the regulatory process?

NRx plans to file an NDA for Accelerated Approval for NRX-101 in patients with bipolar depression and suicidality or akathisia, leveraging its Breakthrough Therapy designation for expedited development.