OTIPRIO SIDE EFFECTS

SIDE EFFECTS

Clinical Trials Experience

Because clinical studies are conducted under widely varying conditions, adverse reaction rates observed in the clinical studies of a drug cannot be directly compared to rates in the clinical studies of another drug and may not reflect the rates observed in practice.

Otitis Media With Effusion

In two randomized, sham-controlled Phase 3 clinical trials, 530 pediatric patients with bilateral otitis media with effusion undergoing tympanostomy tube placement were treated with OTIPRIO or sham administered intratympanically as a single dose. The median age of the pediatric patients enrolled in the clinical trials was 1.5 years; 62% of patients were 6 months through 2 years of age and 38% of patients were greater than 2 years of age.

Adverse reactions that occurred in at least 3% of OTIPRIO patients and at an incidence greater than sham are presented in Table 1.

Table 1: Adverse Reactions in Phase 3 Otitis Media with Effusion Trials

Acute Otitis Externa

In a single randomized, sham controlled Phase 3 clinical trial, 259 pediatric and adult patients with acute otitis externa were treated with OTIPRIO or sham administered by a healthcare professional to the external ear canal as a single dose (0.2 mL to each affected ear). The median age of the patients enrolled in the clinical trial was 34 years; 26% were pediatric patients (age 3 to 17 years), 65% were adults (age 18 to 64 years), and 8% were elderly patients (age 65 years and older).

Adverse reactions that occurred in at least 2% of OTIPRIO patients and at an incidence greater than sham are presented in Table 2.

Table 2: Adverse Reactions in Phase 3 Acute Otitis Externa Trial