OTIPRIO is a physician administered, single dose formulation of ciprofloxacin in development for the treatment of patients with acute otitis externa, also known as swimmer’s ear, and patients with acute otitis media with tympanostomy tubes.
Acute Otitis Externa (AOE) Program
In July, we announced that our Supplemental New Drug Application (sNDA) for the approval of OTIPRIO as a treatment for patients with AOE was accepted for filing by the FDA and assigned a Prescription Drug User Fee Act (PDUFA) action date of March 2, 2018. The sNDA was based on positive results from a Phase 3 trial that evaluated a single administration of 12 mg OTIPRIO (equal to 0.2 mL) vs. sham (no treatment) in 262 pediatric and adult patients. In this trial, OTIPRIO met the primary endpoint by showing a statistically significant increase in clinical cure rate compared to sham at Day 8 (p<0.001) where clinical cure was defined as complete resolution of the signs and symptoms related to AOE. OTIPRIO also demonstrated a statistically significant superiority to sham in clinical cure rate at all other time points assessed including Day 4 (p=<0.021), Day 15 (p<0.001) and Day 29 (p<0.001), and was well-tolerated.
Acute Otitis Media with Tympanostomy Tubes (AOMT) Program
We have successfully completed a Phase 2 trial of OTIPRIO in pediatric patients with AOMT. This trial demonstrated that both OTIPRIO doses, 6 mg (0.1 mL) and 12 mg (0.2 mL), were well-tolerated and achieved higher and statistically significant (p<0.05) clinical cure rates over sham (no treatment). In June, we successfully completed an End-of-Phase 2 review with the FDA for OTIPRIO in the treatment of pediatric patients with AOMT. Based on the feedback received from the FDA, we plan to conduct a single, sham controlled, pivotal Phase 3 trial enrolling approximately 200 pediatric patients with AOMT to support approval of OTIPRIO for this indication. The timing for initiation of this trial has not yet been determined.