A Pharmacokinetic Study to Assess Dose Proportionality, Safety and Tolerability of Diazepam Nasal Spray in Healthy Adult Volunteers

• diazepam nasal spray (Drug), also known as PLUMIAZ™ (diazepam) Nasal Spray: diazepam nasal spray at two dose levels (DL). One dose of diazepam nasal spray is administered as two intranasal sprays; one in each nostril using a nasal spray device.

Primary outcomes

• Maximum measured plasma concentration (Cmax) [within 15 minutes prior to dosing and at specified time points up to 24 hours post-dose]
• Area under the concentration curve from time 0 to the concentration at 24 hours (AUC0-24) [within 15 minutes prior to dosing and at specified time points up to 24 hours post-dose]
• Area under the concentration curve from time 0 to infinity (AUCinf) [within 15 minutes prior to dosing and at specified time points up to 24 hours post-dose]
• Apparent total body clearance of drug from plasma (CL/F) [within 15 minutes prior to dosing and at specified time points up to 24 hours post-dose]

Secondary outcomes

• Number of patients with adverse events (AEs) including serious AEs [up to 21 days]
• Change in focused nasal exam [within 30 minutes prior to dosing and at specified time points up to 24 hours post-dose]
• Taste change questionnaire [from 5 minutes up to 24 hours post-dose]: If patient reports a change in taste associated with diazepam nasal spray, questionnaire to be completed by research staff.

Sex: All, ages: 18 Years to 65 Years, accepts healthy volunteers

Inclusion Criteria:

* Screening body weight 88 to 111 kg, inclusive;
* General good health with no clinically significant abnormalities that would affect ability to complete study as determined by medical history, physical examination, visual evaluation of the septum and turbinates to document baseline anatomy, electrocardiogram, clinical laboratory test results;
* Negative drug and alcohol testing;
* Negative pregnancy test for female subjects of childbearing potential.

Exclusion Criteria:

* Subject who is not surgically sterile or female subject who is less than 2 years postmenopausal, and who does not agree to use a highly effective birth control method during the study and up to 3 months after the last dose of investigational product;
* In the judgment of the Investigator, any clinically significant abnormality (such as septal perforations) or illness that would interfere with participation in this study as determined by medical history, physical examination (including visual exam of septum and turbinates), ECG, clinical laboratory results, or other screening safety tests;
* Any other condition and/or situation that causes the investigator to deem a subject unsuitable for the study.

• David Squillacote, MD, Study director, Acorda Therapeutics