Open Label Extension to Assess the Long-Term Safety and Tolerability of ZYN002 in Children and Adolescents With FXS

This is an open-label extension, multiple-center study, to assess the long-term safety and
tolerability of CBD administered as ZYN002, a transdermal gel, for the treatment of child and
adolescent patients with Fragile X Syndrome (FXS). Male and female patients with FXS will be
treated for up to 12 months. Up to 300 male and female patients, ages 3 to 18 years will be
enrolled.

Parents/caregivers will apply the study gel twice daily for the 52-week treatment period.

Participants who weigh less than or equal to 35 kg, will receive 1 sachet of ZYN002, applied
every 12 hours (± 2 hours).

Participants who weigh more than 35 kg will receive 2 sachets of ZYN002, applied every 12
hours (± 2 hours).

At the Investigator's discretion, the dose may be increased to a total of 4 sachets a day or
decreased to a total of 2 sachets a day any time after the first month of treatment.

Participants whose weight changes during the course of the study may have their doses changed
at the investigator's discretion on or after the Month 1 visit, or reduced due to
tolerability issues at investigator's discretion.

Participants who are taking anti-epileptic drugs may have an additional one or two weeks of
treatment after the 52 week treatment period to taper off study treatment.

Blood samples will be collected for safety analysis of ZYN002. Additionally, the
parents/caregivers will be asked to complete some questionnaires. There will be other
questionnaires and scales that will be completed at the site by the study doctor and/or with
the participant and their parents/caregivers.

Inclusion Criteria:

- Participated in the ZYN2-CL-016 study.

- Patients and parents/caregivers agree to abide by all study restrictions and comply
with all study procedures.

- Patients and parents/caregivers must be adequately informed of the nature, risks of
the study, and give written informed consent prior to enrollment in ZYN2-CL-017.

- In the Investigator's opinion, the patients and parents/caregivers are reliable and
are willing and able to comply with all protocol requirements and procedures.

- Females of childbearing potential must have a negative pregnancy test at all
designated visits

Exclusion Criteria:

- Patient is receiving any investigational drugs (not ZYN002) or using any experimental
devices.

- Patient has an ongoing serious adverse event (SAE) or has experienced a SAE in
ZYN2-CL-016, which in the opinion of the Investigator, should exclude them from
participation.

- Females who are pregnant, nursing, or planning a pregnancy; females of childbearing
potential and male patients with a partner of childbearing potential who are unwilling
or unable to use an acceptable method of contraception for the duration of therapy and
for three months after the last dose of trial drug.

- Patients who have alanine aminotransferase (ALT), aspartate aminotransferase (AST), or
total bilirubin levels >= 2 times the upper limit of normal (ULN) or has alkaline
phosphatase levels >= 3 times the ULN as determined from patient safety laboratories.