The U.S. health regulator has declined to approve a nasal spray that would have been the first needle-free emergency treatment for allergic reactions, a surprise decision that sent shares of its developer ARS Pharmaceuticals down 47% premarket.
Despite failing a previous late-stage study, VistaGen’s fasedienol finally scored a win by meeting its primary endpoint and strongly easing distress among patients with social anxiety disorder.
Today the company decided to cut 400 jobs and scale back operations at some its facilities, pivoting its focus on core products such as overdose reversal nasal spray Narcan and anthrax vaccines.
Indivior’s Opvee is an emergency nasal spray medication to reverse opioid overdose approved for patients aged 12 years and above with signs of respiratory or central nervous system depression.
Despite concerns regarding neffy’s lack of clinical evidence, the panel of experts voted in favor of the nasal spray’s approval for the emergency treatment of type 1 allergic reactions.
The approval for OTC use of the naloxone-based nasal spray will help align the federal government’s stance with states that have provisions to offer the drug without prescription at pharmacies.
The approval of Zavzpret gives patients access to a potentially fast-acting option to treat their headaches.