Open-label Safety and Efficacy of SPN-812 (Viloxazine Extended-release Capsule) in Adults With ADHD and Mood Symptoms

Inclusion Criteria:

To be eligible for participation in this study, a participant must meet all of the following criteria:

1. Is male or female, ≥18 years of age.

2. Is willing and capable of providing and signing electronic informed consent.

3. Has a primary diagnosis of ADHD based on the Diagnostic and Statistical Manual ofMental Disorders; Fifth Edition, Text Revision (DSM-5-TR) as confirmed with theMini-International Neuropsychiatric Interview for ADHD Studies (MINI-AS).

4. Has an AISRS Total score ≥24 at Screening.

5. Has a CGI-S score ≥3 at Screening.

6. Has a MADRS (SIGMA) Total score >22 at Screening and/or HAM-A (SIGH-A) Total score >22 at Screening.

7. If potential participant is a biological female, one of the following (a, b, or c)must be met:

8. Has undergone menopause, defined as a biological female who reports amenorrheafor at least 12 consecutive months prior to providing informed consent.

9. Is a non-pregnant Female of Childbearing Potential (FOCP) who is not seekingfertility treatment during the study and agrees to use one of the followingacceptable birth control methods beginning 14 days prior to the first dose ofstudy medication, throughout the study while taking study medication, and for 7days following the last dose of study medication: i. Hormonal contraceptive;ii.Barrier method: simultaneous use of male condom and diaphragm or cervicalcap with spermicidal foam/gel/film/cream/suppository.

10. Has had bilateral tubal ligation, hysterectomy, bilateral oophorectomy (permanently sterilized) at least 6 months prior to providing informed consent.

11. If potential participant is a biological male, one of the following must be met:

12. Is capable of having children and agrees to use 2 methods of contraceptionbeginning 14 days prior to the first dose of study medication, throughout thestudy while taking study medication, and for 7 days following the last dose ofstudy medication.

13. Has had sterilization surgery (permanently sterilized) at least 6 months priorto providing informed consent.

14. Owns a functioning smartphone device, has access to an internet connection (Wi-Fi ordata plan), is willing to download and use the study mobile app throughout thestudy, and is willing to have visual telemedicine appointments (televisits) at timesdesignated in the study protocol.

Exclusion Criteria:

A participant who meets any of the following criteria will be excluded from participation in the study:

1. Has a history of substance use disorder (alcohol, opioids, etc.) within the last 6months prior to providing informed consent with exception of nicotine and cannabis.

2. Is currently taking or has taken Qelbree for treatment of ADHD in the last 3 monthsor is currently taking another non-stimulant medication for treatment of ADHD, likeatomoxetine (Strattera), Clonidine (Catapres, Kapvay) or Guanfacine (Tenex,Intuniv). Stimulant medications for ADHD and most medications for mood symptoms (symptoms of depression and/or anxiety) are allowed.

3. Is taking a prohibited concomitant medication per the Qelbree prescribinginformation.

4. Is a FOCP who is pregnant, nursing, sexually active with a male partner and notwilling to use one of the acceptable birth control methods throughout the studyand/or is seeking fertility treatment.

5. Has a history of moderate or severe head trauma or other neurological disorder orsystemic medical disease that, in the Investigator's opinion, is likely to affectcentral nervous system functioning. This would include participants with:

6. A current diagnosis of a major neurological disorder; or

7. Seizures, seizure disorder or seizure-like events; or a history of seizuredisorder within the immediate family (siblings, parents); or

8. Encephalopathy

9. Has attempted suicide within the 6 months prior to the C-SSRS assessment atScreening, or is at significant risk of suicide, either in the opinion of theInvestigator or defined as a "yes" to suicidal ideation questions 4 or 5 oranswering "yes" to suicidal behavior on the C-SSRS within the 6 months prior to theC-SSRS assessment at Screening.

10. Is currently participating in another clinical trial or has participated in aclinical trial within the 60 days prior to providing informed consent.

11. Has any history of schizophrenia, schizoaffective disorder, or bipolar disorder, orhas any other psychiatric disorders in the investigator's clinical judgement wouldinterfere with their ability to participate in the study.

12. Has any unstable, clinically significant cardiovascular condition that in theinvestigator's clinical judgement would preclude their participating in the study.

13. Has any disease or taking any medication that could, in the Investigator's opinion,interfere with the assessments of safety, tolerability, or efficacy, or interferewith study conduct or interpretation of results.

14. History of unexplained loss of consciousness, unexplained syncope, unexplainedirregular heartbeat or palpitations or near drowning with hospital admission.

15. In the Investigator's opinion, is unlikely to comply with the protocol or isunsuitable for any other reason.