Adamis Pharmaceuticals Corp. said the U.S. Food and Drug Administration accepted for review its application for a higher dose of naloxone to treat opioid overdose.
The company's new drug application covers an injectable version of the medicine. The agency is expected to make a decision by Oct. 31.
Naloxone works by blocking or reversing the effects of opioids, such as extreme drowsiness, slowed breathing or loss of consciousness. A nasal spray version of the drug is marketed by Adapt Pharma Operations Ltd. under the Narcan brand. Meanwhile, kaleo Inc. offers Evzio, an autoinjectable version of the opioid overdose therapy.
San Diego-based Adamis Pharmaceuticals develops and sells products for various therapeutic areas, including respiratory disease and allergy.