Open-Label and Single-Arm Study of MYOBLOC® in the Treatment of Troublesome Sialorrhea in Adults

Multicenter, open-label, outpatient study of the safety and effectiveness of repeated doses
of MYOBLOC over a 1-year duration in adult subjects with troublesome sialorrhea. The primary
goal is to determine the long-term safety and tolerability of MYOBLOC (administered
intraglandularly as single total dose of 3,500 Units) treatments every 13 weeks over a
maximum possible duration of 1 year in adult subjects with troublesome sialorrhea. The
secondary goal is to assess the magnitude of therapeutic response of MYOBLOC (administered
intraglandularly as a single total dose of 3,500 Units) using effectiveness assessments
performed at intervals after treatments every 13 weeks over a maximum possible duration of 1
year.

Inclusion Criteria:

- Seeking treatment for troublesome sialorrhea for at least 3 months that is occurring
secondary to any disorder or related to any cause, including, but not limited to,
Parkinson's Disease (PD), adult cerebral palsy, amyotrophic lateral sclerosis (ALS),
stroke, traumatic brain injury, oral cancer, and side effects of other medications.

- Able to read and provide written informed consent before enrollment into the study, or
the subject's caregiver (Legally Authorized Representative) can provide written
informed consent.

- Male or female, 18 to 85 years of age (inclusive).

- Minimum unstimulated salivary flow rate of 0.2 g/min at screening

- Minimum Investigator's Drooling Frequency and Severity Scale (DFSS) score of 4 at
screening.

- Ability and availability to participate in the study for up to 1 year (ALS subjects:
ability and availability to participate in the study for at least 6 months), based on
overall health of the subject and disease prognosis

Exclusion Criteria:

- A moderate to high risk of aspiration will exclude participation in this study.
Subjects whose risk of aspiration are judged by the Investigator to be satisfactorily
controlled by placement of PEG tube or G-tube for nutritional support are eligible to
participate.

- Respiratory forced vital capacity (FVC) of <20% of predicted

- Prior botulinum toxin type A or B treatment in the salivary gland(s) identified for
treatment in this study within 24 weeks before screening. Prior botulinum toxin type A
or B treatment into other anatomical regions not selected for treatment in this study
is not exclusionary, but must have occurred at least 12 weeks before screening

- Subjects should be excluded if, in the Investigator's opinion, the subject failed to
respond to previous treatment with botulinum toxin. Subjects should not receive nor
have any plans for receiving any botulinum toxin treatment, other than the study drug
(MYOBLOC), during the entire course of the study (from the point the informed consent
is signed until subject's participation is complete).

- Concomitant use, or exposure within 5 half-lives of screening, of aminoglycoside
antibiotics, curare-like agents, or other agents that interfere with neuromuscular
function

- Prior salivary gland surgery

- Current treatment or treatment at any time during the study with Coumadin® (warfarin)
or similar anti-coagulant medications. Anti-platelet medications are not specifically
exclusionary

- Evidence of any clinically significant neurologic disease

- Pregnancy or lactation

- Anticipated or scheduled surgery during the study period. A PEG tube/G tube may be
placed for nutritional support at any time during the study and will not exclude the
subject from continued study participation.

- Major surgery (requiring general anesthesia, except PEG tube/G tube placement ) within
the previous 6 months before screening.

- Current infection at the sialorrhea treatment injection site(s)

- History of drug or alcohol abuse currently or within the previous 6 months

- Participation in another clinical drug, device, or biological agent study within 30
days of screening or while participating in this study