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Otonomy, Inc., a biopharmaceutical company, announced positive results from its pivotal phase 3 clinical trial of Otiprio (ciprofloxacin otic suspension) in patients with acute otitis externa (AOE), also known as swimmer's ear.
This single administration trial of Otiprio met the primary endpoint by showing a statistically significant increase in clinical cure rate compared to sham (no treatment) at Day 8 (p<0.001). Treatment with Otiprio was also well tolerated. Based on these positive results, Otonomy expects to submit a supplemental New Drug Application (sNDA) with the US Food and Drug Administration (FDA) in the first half of 2017.
“These positive pivotal trial results further our label expansion plans for Otiprio, and the clinical cure rates demonstrated following a single administration of Otiprio are comparable to ITT results with commonly used antibiotic ear drops that require two or three doses per day for a week,” said David A. Weber, Ph.D., president and CEO of Otonomy. "This trial reinforces Otiprio's unique profile as a single-dose product administered by a physician thereby eliminating the risk of patient non-compliance with the use of multi-dose, multi-day ear drops. Furthermore, the fact that approximately 70% of patients in this trial were treated by non-ENT physicians supports the utility of Otiprio outside the ENT specialist audience."
The one-month, prospective, randomized, double-blind, sham-controlled, multicenter, phase 3 clinical trial enrolled a total of 262 pediatric and adult patients with acute otitis externa. Patients were randomized to receive a single administration of 12 mg Otiprio (equal to 0.2 mL) or sham (empty syringe) to the external ear canal of the affected ear(s). The primary endpoint was clinical cure at Day 8 defined as complete resolution of the signs and symptoms related to acute otitis externa (i.e. tenderness, erythema, and edema) as determined by a blinded clinical assessor. Clinical cure was also assessed at Day 4, Day 15, and Day 29. Safety outcome measures included reporting of adverse events and otoscopic examinations. Otonomy plans to present the full results at an appropriate medical meeting in the future.
Acute otitis externa (AOE), also known as swimmer’s ear, is a common condition involving infection and inflammation of the external ear canal typically caused by bacterial infection. According to medical claims data, there are nearly 4 million episodes of AOE each year in the United States.
Otiprio (ciprofloxacin otic suspension) is a fluoroquinolone antibacterial indicated for the treatment of pediatric patients with bilateral otitis media with effusion undergoing tympanostomy tube placement. Otiprio is administered by a physician as a single 0.1 mL (6 mg) intratympanic administration into each affected ear, following suctioning of the middle ear effusion. The thermosensitive suspension exists as a liquid at or below room temperature and gels when warmed. In two Phase 3 trials, a single intraoperative administration of Otiprio demonstrated a statistically significant reduction in the cumulative proportion of study treatment failures compared to tubes alone (p-value <0.001).
