Study to Assess the Safety, Tolerability and Pharmacokinetic Profile of MNS075 (Intranasal Morphine)

An Open Label, Randomized, Single Center, Repeat Dose Study to Assess the Safety, Tolerability and Pharmacokinetic Profile of MNS075 (Intranasal Morphine) in Opioid naïve, Healthy Adult Volunteers

The purpose of this study is to characterize the repeat dosing plasma profile, extent of accumulation and repeat dose pharmacokinetics of morphine, morphine-3-glucuronide, and morphine-6-glucuronide during administration of MNS075 in two different, clinically-relevant dosing schedules.

This study is an open label, randomized, two-treatment, two-period, two-sequence, single-center, crossover study comparing the pharmacokinetics, safety and tolerability of MNS075 (intranasal morphine) at doses of 7.5 mg self-administered q1h for 7 hours (8 doses) and 15 mg self-administered q3h for 9 hours (4 doses).

Inclusion Criteria:

• Healthy adult volunteers 18 years of age or older

Exclusion Criteria:

• History of alcohol, drug addiction, or substance abuse.
• Known to or suspected to be currently abusing alcohol or drugs.
• Allergy or hypersensitivity to shellfish or opioids.
• History of seizures.
• Clinically significant structural or functional abnormalities of the nose and upper airway, obstruction of the nasal passages, or mucosal lesions of the nostrils.
• Smoked or used tobacco or nicotine products in the past six months or expects to during the study.
• Positive for hepatitis B or hepatitis C or HIV antibodies.