Novus Therapeutics, Inc. announced that it has dosed the first adult patient with acute otitis media in a phase 1 clinical trial of OP0201, the company’s lead product candidate being developed for otitis media. This phase 1 study will provide additional safety information in adults with acute otitis media and will help in better understand the onset of symptom relief following an initial dose of OP0201. Study OP0201-C-004 (“C-004”) is a phase 1 clinical trial designed to evaluate safety and relief of ear pain following a single intranasal dose of OP0201 over a 60-minute observation period in 24 adults with acute otitis media. The randomized, double-blind, placebo-controlled, parallel-group trial will explore the effects of a 20 mg intranasal dose of OP0201. Assessment of pain relief will be captured utilizing a Visual Analog Scale (VAS), Numeric Rating Scale (NRS-11), Patient Global Impression of Change (PGIC), and Clinical Global Impressions Scale: Global Improvement (CGI-I). The multicenter study will be conducted in the United States. Additional information about the study can be found at clinicaltrials.gov using the identifier NCT03766373.