In Avadel’s REST-ON clinical trial, once-at-bedtime LUMRYZ demonstrated statistically significant and clinically meaningful improvements across all co-primary endpoints, specifically improving the amount of time that patients could stay awake, an overall improvement as assessed by their clinicians, and a reduction in cataplexy, which is sudden muscle weakness that people with Narcolepsy Type 1 experience, typically in response to an emotion, such as laughter or surprise. Cataplexy may be as profound as full-body collapse, or may be more subtle, such as dropping items or slurred speech. 

In July 2022, LUMRYZ received FDA Tentative Approval for the treatment of cataplexy or excessive daytime sleepiness in adults with narcolepsy. FDA Tentative Approval means that a medication has demonstrated efficacy, safety, and manufacturing quality. However, due to a patent that is listed in the FDA’s Orange Book, a final approval decision cannot be given until after disposition of the patent. In this regard, the US District Court for the District of Delaware recently ruled that the patent blocking a final approval decision for LUMRYZ was improperly listed and ordered the patent removed from the FDA’s Orange Book. Upon removal of that patent from the Orange Book, Avadel will be able to request a transition from Tentative Approval to Final FDA Approval. 

Our delay in final FDA approval has not deterred us from our mission: we know patients are desperate for an option that will not require a forced, middle-of-the-night awakening, and they motivate us to ensure we urgently bring LUMRYZ to the narcolepsy community. 

Our Values are key to how we will fulfill this promise; at Avadel, it was imperative that these are not simply printed words, but that they imbue how we will serve patients – with LUMRYZ and beyond. 

Avadel Values 

In everything we do, we consider the patient experience, listening to their needs as we pursue the development and delivery of medicines that will have the most meaningful impact on those we serve.

We live the Avadel values so we can be the best for our patients, our community, and each other.

· Relentless

We are relentless in our pursuit of solutions to address the challenges patients face with current treatment options. We have the tenacity and burning desire to overcome obstacles and never give up. We act with a sense of urgency because we understand that patients shouldn’t wait for innovative solutions. We passionately believe in what we are doing and whom we are doing it for – the patient.

· Confidence with Humility

We are confident in our ability to recognize and overcome the challenges before us, yet we know when to ask for support. We are confident in our individual expertise, yet humble enough to know we don't have all the answers. We push each other to be our best and treat each other with respect. 

· Courageous

We recognize that it takes courage to make the bold decisions that can have the greatest impact for patients. We ask the tough questions because if not us, then who? Our diverse team sees our challenges as our biggest opportunities and continually pushes outside of their comfort zones to drive meaningful progress.

· Insights to Impact

We listen to our stakeholders, use data to drive decisions, and act on what we learn. We use insights to identify opportunities and take actions that deliver the greatest impact for patients. Our efforts are thoughtful and evidence-based, resulting from a deep understanding of what it takes to effect meaningful change for patients and those who care for them.

· Togetherness

We strive to create a level of connectivity that goes beyond working together. Rooted in the trust we earn every day, our team is inclusive, valuing diverse perspectives and work every day to lift each other up in pursuit of improving the lives of the patients we serve. This translates into one team driving success for each employee, success for the company, and most importantly, success for every patient.