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Currently, there are no approved on-hand rescue treatments for acute anxiety episodes or panic attacks

There are more than 40 million people in the United States with anxiety disorders. Acute agitation episodes can occur in all major types—generalized anxiety, obsessive-compulsive disorder, post-traumatic stress disorder, social phobia, and panic disorder. Up to 75% of patients with panic disorder will experience an acute panic attack—even though they may be taking daily chronic therapy, these attacks can be terrifying and impact approximately 2.4 million adults annually.
Presently, there are no FDA-approved products indicated for the treatment of acute anxiety episodes.

About NRL-2

We are developing NRL-2, a proprietary nasal spray formulation of a benzodiazepine (other than diazepam) and Intravail®, for the treatment of acute panic attacks in patients with panic disorders (PD), general anxiety disorders (GAD) and other related anxiety disorders.* There are multiple oral therapies approved by the FDA for depression and GADs, but there are currently no medications approved by the FDA for the treatment of acute panic attacks. We believe that NRL-2, if approved, could provide the patients suffering from acute panic attacks with a rapid onset treatment option for acute panic attacks. We expect to submit an IND and begin clinical trials in 2022.

*NRL-2 is an investigational drug candidate being developed for children and adults who require intermittent use of benzodiazepines for acute anxiety episodes and has not been approved by FDA for any indication.