© Reuters. FILE PHOTO: A field of NARCAN nasal spray is photographed at an outpatient remedy middle in Indiana, Pennsylvania, U.S. on August 9, 2017. REUTERS/Adrees Latif
(Reuters) -Contract drugmaker Emergent Biosolutions (NYSE:) stated on Tuesday its over-the-counter nasal spray as a remedy for suspected opioid overdose can be reviewed on a precedence foundation by the U.S. well being regulator.
Emergent is searching for the U.S. Meals and Drug Administration’s approval for a prescription-free sale of its nasal spray, Narcan, which is already cleared for the remedy of opioid overdose within the nation.
If accredited following the company’s precedence overview by March 29, the spray might turn out to be the primary naloxone-based drug to be bought over-the-counter.
If accredited, Narcan is more likely to face competitors from generic variations of the drug which can strain margins for Emergent, Cowen analyst Boris Peaker stated in a observe.
Rival Opiant Prescribed drugs (NASDAQ:) Inc’s drug nalmafene, which can be underneath overview in america, might pose a further danger to Narcan gross sales because it supplies higher safety in opposition to opioid overdose, Peaker added.
Emergent’s announcement comes a number of weeks after the company stated naloxone is perhaps protected and efficient for over-the-counter use in some types, doubtlessly paving the way in which for its use federally.
There are authorized limitations limiting entry to naloxone in some states, and even in others the drug isn’t at all times obtainable to these most liable to an overdose.
The worsening opioid disaster has prompted U.S. President Joe Biden’s administration to develop newer methods, together with using naloxone.
Authorities information estimates that there have been greater than 100,000 drug-related overdose deaths within the nation throughout 2021, a close to 15% enhance from the yr earlier.
The Maryland-based firm stated its software to the well being regulator consists of information that helps protected and efficient use of Narcan based mostly on usability and greater than 5 years of post-marketing research.
Earlier within the day, the corporate’s shares rose almost 3% earlier than reversing course to commerce decrease almost 2%.
