NRx Says New Formulation of IV Ketamine Could Be Delivered Subcutaneously

HTX-100 could enable “the administration of ketamine in insulin-pump-like devices in the clinic setting,” according to NRx.

NRx Pharmaceuticals said the company has developed a novel, proprietary formulation of IV ketamine for use as HTX-100.

The drug’s pH-neutral formulation could enable both intravenous and subcutaneous administration, according to NRx, which plans to market HTX-100 through its wholly owned subsidiary, HOPE Therapeutics.

HTX-100 could enable “the administration of ketamine in insulin-pump-like devices in the clinic setting, eliminating the requirement for intravenous-infusion personnel,” NRx added.

Developed in partnership with Nephron Pharmaceuticals, a South Carolina-based manufacturer of sterile pharmaceutical products, the formulation likely will generate one or more patents, according to NRx.

“This new formulation has the key advantage of achieving neutral pH, in contrast to the acidic pH of generic formulations of ketamine,” NRx said in a news release. “Acidic substances are tolerated when diluted for intravenous use, but cause pain and may cause skin ulcers if administered subcutaneously.”

Ketamine was first synthesized in the early 1960s and was used extensively during the Vietnam War as a battlefield anesthetic. Since then, however, the formulation of IV ketamine was remained “relatively static,” according to Dr. Jonathan Javitt, who described HTX-101 as “an improved formulation ready for use in modern science.”

“Development of a pH-neutral, subcutaneous form of ketamine administration enables a significantly less complex route of administration in the outpatient setting,” Javitt said. “Moreover, advances in insulin-pump technology create the potential to monitor the brain-wave activity and other physiologic parameters associated with ketamine administration and modulate ketamine therapy based on the patient’s individual physiologic response.”