Safety and Tolerability Study of Diazepam Buccal Soluble Film (DBSF) in Subjects With Epilepsy

The Primary objective of the study is to assess the safety and tolerability of DBSF (study
drug) administered to subjects with epilepsy for the treatment of seizures over a minimum
12-month period.

Secondary objectives of the study are;

- To evaluate the usability of study drug as assessed by the ability of
caregivers/subjects to administer study drug based on the Instructions for Use (IFU).

- To evaluate the Quality of Life of the subjects during the study drug treatment period
as assessed by age appropriate use of epilepsy scales [Pediatric Quality of Life
Inventory (PedsQL), Quality of Life in Epilepsy Inventory (QOLIE) 39 and Quality of Life
in Epilepsy Inventory (QOLIE) 49] over a minimum 12-month period.

Inclusion Criteria:

1. Female or male subject between the ages of 2 and 65 years of age, inclusive

2. Written informed consent to participate in the study

3. Subject has an established diagnosis of epilepsy either partial or generalized
epilepsy with motor seizures with clear alteration of awareness, and while on a
regimen of anti-epileptic medication(s), still experiences bouts of seizures (frequent
break through seizures, e.g. ARS or seizure clusters) and who, in the opinion of the
Investigator, may need benzodiazepine intervention for seizure control at least 1 time
a month on average.

4. Caregiver, if needed for subject, provides written informed consent and is able to
administer study drug in the event of a seizure.

5. Female subjects ≥12 years of age have a negative serum pregnancy test at screening.
Female subjects of childbearing potential, (not surgically sterile or less than 2
years postmenopausal), must have a partner who is sterile, agrees to abstinence, be
practicing double barrier contraception or using an FDA approved contraceptive (e.g.,
licensed hormonal or barrier methods) for greater than 2 months prior to screening
visit and commit to an acceptable form of birth control for the duration of the study
and for 30 days after the study

6. No aspects of the medical history and/or the physical-neurological examination that at
the judgment of the Investigator, in consultation with the Sponsor, will interfere
with administration or absorption of study drug, or could evolve into a safety issue

7. No clinically significant abnormal findings on the electrocardiogram (QTcF≤450 msec
for males and QTcF≤470 msec for females)

8. Subject and caregiver must be willing to comply with all study visits and all required
study procedures

Exclusion Criteria:

1. A history of clinically significant gastrointestinal, renal/genitourinary, hepatic,
hematologic, dermatologic, endocrine, oncologic, pulmonary, immunologic, psychiatric,
or cardiovascular disease, or any other clinically significant abnormalities, such as
physical examination, vital signs, laboratory tests or ECG at Screening or Baseline
which in the opinion of the investigator require further investigation or treatment or
which may interfere with study procedures or safety or other medical conditions (e.g.,
cardiac, respiratory, gastrointestinal, psychiatric, renal disease) which are not
adequately and stably controlled, or which in the opinion of the investigator(s) could
affect the subject's safety or interfere with the study assessments or any other
condition which, in the opinion of the Investigator, would jeopardize the safety of
the subject

2. Subject has had significant traumatic injury, major surgery or open biopsy within 30
days prior to study screening

3. Subject with an active major depression or a past suicide attempt, or any suicidal
ideation of 4, or 5 or any suicidal behavior in lifetime using C-SSRS. The pediatric
C-SSRS should be used for subjects 6 to 11 years of age. The adult C-SSRS should be
used for subjects ≥12 years of age. Note that this exclusion is only applicable to
cognitive-appropriate subjects who are able to understand and complete the Suicide
Rating Scale

4. A history of allergic or adverse responses to diazepam or any other benzodiazepine

5. Participation in a clinical trial other than MonoSol Rx Phase 2 studies 160325 and
160326 within 30 days prior to Day 0. Participation in an observational
(non-interventional) study is not an exclusion, provided that there are no scheduling
conflicts with this study. Received any other investigational medication (unless it
can be documented that the subject received only placebo) or device within 8 weeks or
5 half-lives (whichever is longer) before assignment to study drug treatment

6. Lactating female or positive serum pregnancy test (ß-hCG) at screening for female
subjects ≥12 years of age

7. Positive blood screen for HIV, HbSAg, or Hepatitis C, or a positive urine screen for
alcohol or drugs of abuse, except marijuana use for medicinal indications. When
marijuana is or was used for medicinal indications in the opinion of the Investigator,
it is not considered as drug abuse and the subject can be enrolled in states where
medical marijuana use is legal, even if the marijuana metabolites in the urine
revealed as positive