The primary objective of this study is to evaluate the analgesic efficacy of DEX-IN compared with placebo and active control (fentanyl), in subjects undergoing painful outpatient and office based procedures.

Inclusion Criteria:

• Voluntarily provide written informed consent
• Be planned to undergo a selected office-based or outpatient procedure
• Be naïve to the planned procedure, i.e. no repeated or revision procedures
• Not pregnant or planning to become pregnant, or using appropriate contraceptive measures.

Exclusion Criteria:

• Known allergy to any study treatment or excipient
• Have another painful physical condition or anxiety related diagnosis that may confound study assessments
• Evidence of a clinically significant finding on physical examination, laboratory assessment, or ECG
• Have signs or a history of significant nasal condition that may interfere with intranasal drug delivery

All randomized subjects

7 Days

Double-blind, double-dummy