RADNOR, Pa. - NRx Pharmaceuticals, Inc. (NASDAQ:NRXP), a clinical-stage biopharmaceutical company, today announced the development of a novel ketamine formulation, HTX-100, which achieves a neutral pH level, potentially allowing for both intravenous (IV) and subcutaneous (SQ) administration.
This advancement contrasts with the acidic nature of existing generic ketamine formulations, which are suitable for IV use but can cause pain and skin ulcers if administered subcutaneously.
The new formulation is based on prior patents by NRx founder and is expected to result in Composition of Matter patent protection. The company anticipates generating additional patents related to the composition or formulation of the product. HTX-100 is expected to be marketed by HOPE Therapeutics, Inc., a wholly owned subsidiary of NRx.
Dr. Jonathan Javitt, Founder, Chairman, and Chief Scientist of NRx Pharmaceuticals, highlighted the significance of the new formulation, "The current formulation of IV Ketamine was developed for battlefield use in the 1960s and has remained relatively static since then.
With our new formulation, and Nephron's state of the art manufacturing expertise, we are pleased to be approaching the market with an improved formulation ready for use in modern medicine."
The proprietary formulation was developed in partnership with Nephron Pharmaceuticals, a leading sterile products manufacturer. It may enable the use of ketamine in devices similar to insulin pumps in clinical settings, potentially reducing the need for intravenous infusion personnel.
NeuroRx, Inc. previously entered into a joint development agreement with a manufacturer of insulin pumps, awaiting a suitable pH-neutral ketamine formulation.
NRx Pharmaceuticals focuses on developing therapeutics for central nervous system disorders, including suicidal bipolar depression, chronic pain, and PTSD. The company is working on NRX-101 for suicidal treatment-resistant bipolar depression and chronic pain, which has been designated as an investigational Breakthrough Therapy by the FDA.
The company plans to submit a New Drug Application for HTX-100 in the treatment of suicidal depression, bolstered by results from clinical trials conducted under the auspices of the US National Institutes of Health and data from French health authorities.
This news is based on a press release statement from NRx Pharmaceuticals, Inc.
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