Tuesday, July 13, 2021

Nasus posts data on Narcan rival, teeing up FDA approval filing

Nasus Pharma has presented data from a pivotal trial of its opioid overdose treatment. The naloxone powder-based nasal spray was absorbed into the blood faster than Narcan, leading Nasus to detail plans to seek FDA approval this year.

The rising number of opioid overdoses caused by fentanyl and other highly potent synthetic opioids has spurred development of more powerful countermeasures. Kaleo developed a higher-dose version of its naloxone auto-injector before going on to discontinue sales, and Opiant Pharmaceuticals landed government support for a nalmefene product based on the drug’s affinity for opiate receptors. 

Nasus is aiming to muscle in on the market. Like the incumbent Narcan, Nasus’ FMXIN001 is a nasal spray formulation of naloxone. By using its microsphere technology on the active ingredient to create uniform spherical particles, Nasus has tried to improve the absorption of naloxone.

The study provides evidence that Nasus has achieved that goal. In the 42-subject study, the area under the curve after nasal administration of FMXIN001 to healthy volunteers was 163% compared to Narcan four minutes after dosing. The area under the curve compared to Narcan slipped to 125% after 10 minutes and to 113% between 10 and 30 minutes. 

“Absorption of our powder-based naloxone to the blood in the first few minutes could signify higher lifesaving effect especially in patients with serious respiratory depression. We are focused on our NDA submission later this year with an objective to commercialize FMXIN001 in 2022,” Nasus CEO Dalia Megiddo, M.D., said in a statement.

Nasus is using AptarGroup’s Unidose Powder System to deliver FMXIN001. The system is already on the market. In 2019, the FDA approved Eli Lilly’s Baqsimi, a treatment of severe hypoglycemia that uses Unidose to deliver a dry nasal spray form of glucagon. 

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