Nasal Carbon Dioxide (CO2)for the Treatment of Temporomandibular Disorders (TMD)Related Pain

Key Inclusion Criteria:

• Have a history consistent with TMD-related pain for at least 3 months prior to screening
• Agree not to use certain medications prior to randomization within the study specified
• Females of childbearing potential must commit to using an acceptable method of birth control and have a negative pregnancy test.

Key Exclusion Criteria:

• Have recent history of alcohol or drug abuse within 2 years prior to randomization
• Current major psychiatric disorder such as suicidal ideation, bipolar, panic disorder, schizophrenic, or psychoses
• History of asthma (other than mild or intermittent)
• Have an existing serious unstable systemic disease (such as severe emphysema, other respiratory diseases, heart disease, etc.) that precludes participation in the study
• Clinically significant nasal disorder (such as deviated septum, presence of polyps, evidence of significant congestion, rhinitis, or other nasal abnormalities)
• Current diagnosis of fibromyalgia
• History or clear clinical evidence of osteoarthritis of temporomandibular joint (TMJ)
• A TMD diagnosis of disc displacement without reduction, "locking"