SAN DIEGO, CA, USA I January 05, 2017 I Otonomy, Inc. (OTIC), a biopharmaceutical company focused on the development and commercialization of innovative therapeutics for diseases and disorders of the ear, today 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 U.S. Food and Drug Administration (FDA) in the first half of 2017.
As shown in the summary table below, treatment with OTIPRIO demonstrated a statistically significant (p<0.05) superiority to sham in clinical cure rate for the intent-to-treat (ITT) population at all time points assessed.
Clinical Cure Rates from Phase 3 AOE Trial (ITT Population)
| |
Day 4 |
Day 8* |
Day 15 |
Day 29 |
| OTIPRIO |
45 |
% |
70 |
% |
75 |
% |
75 |
% |
| Sham |
31 |
% |
49 |
% |
53 |
% |
49 |
% |
| p value |
0.021 |
|
<0.001 |
<0.001 |
<0.001 |
*Primary endpoint
“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.”
About the Phase 3 Trial
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.
About Acute Otitis Externa
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. Symptoms usually appear within a few days of swimming and include itchiness, redness, swelling, pain and pus draining from the infected ear. Antibiotic ear drops are considered the standard of care treatment for AOE with the typical regimen requiring several administrations to the affected ear each day for 7 days.
About OTIPRIO
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).
Important Safety Information for OTIPRIO
Contraindications: OTIPRIO is contraindicated in patients with a history of hypersensitivity to ciprofloxacin, to other quinolones, or to any of the components of OTIPRIO.
Warnings and Precautions – Potential for Microbial Overgrowth: OTIPRIO may result in overgrowth of nonsusceptible bacteria and fungi. If such infections occur, institute alternative therapy.
Adverse Reactions: Adverse reactions (incidence at least 3%) that occurred in two Phase 3 trials with OTIPRIO vs sham were: nasopharyngitis (5% vs 4%), irritability (5% vs 3%), and rhinorrhea (3% vs 2%).
Use in Specific Populations – Pediatric Use: The safety and effectiveness of OTIPRIO in infants below six months of age have not been established.
Full prescribing information can be found at www.OTIPRIO.com.
About Otonomy
Otonomy is a biopharmaceutical company focused on the development and commercialization of innovative therapeutics for diseases and disorders of the ear. OTIPRIO (ciprofloxacin otic suspension) is approved and marketed in the United States for use during tympanostomy tube placement surgery in pediatric patients, and has achieved positive pivotal trial results in patients with acute otitis externa. OTO-104 is a steroid in development for the treatment of Ménière’s disease and other severe balance and hearing disorders. Two Phase 3 trials in Ménière’s disease patients are underway, with results expected during the second half of 2017. OTO-311 is an NMDA receptor antagonist for the treatment of tinnitus that is in a Phase 1 clinical safety trial. Otonomy’s proprietary formulation technology utilizes a thermosensitive gel and drug microparticles to enable single dose treatment by a physician. For additional information please visit www.otonomy.com.
SOURCE: Otonomy
Post Views: 34
SAN DIEGO, CA, USA I January 05, 2017 I Otonomy, Inc. (OTIC), a biopharmaceutical company focused on the development and commercialization of innovative therapeutics for diseases and disorders of the ear, today 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 U.S. Food and Drug Administration (FDA) in the first half of 2017.
As shown in the summary table below, treatment with OTIPRIO demonstrated a statistically significant (p<0.05) superiority to sham in clinical cure rate for the intent-to-treat (ITT) population at all time points assessed.
Clinical Cure Rates from Phase 3 AOE Trial (ITT Population)
| |
Day 4 |
Day 8* |
Day 15 |
Day 29 |
| OTIPRIO |
45 |
% |
70 |
% |
75 |
% |
75 |
% |
| Sham |
31 |
% |
49 |
% |
53 |
% |
49 |
% |
| p value |
0.021 |
|
<0.001 |
<0.001 |
<0.001 |
*Primary endpoint
“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.”
About the Phase 3 Trial
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.
About Acute Otitis Externa
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. Symptoms usually appear within a few days of swimming and include itchiness, redness, swelling, pain and pus draining from the infected ear. Antibiotic ear drops are considered the standard of care treatment for AOE with the typical regimen requiring several administrations to the affected ear each day for 7 days.
About OTIPRIO
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).
Important Safety Information for OTIPRIO
Contraindications: OTIPRIO is contraindicated in patients with a history of hypersensitivity to ciprofloxacin, to other quinolones, or to any of the components of OTIPRIO.
Warnings and Precautions – Potential for Microbial Overgrowth: OTIPRIO may result in overgrowth of nonsusceptible bacteria and fungi. If such infections occur, institute alternative therapy.
Adverse Reactions: Adverse reactions (incidence at least 3%) that occurred in two Phase 3 trials with OTIPRIO vs sham were: nasopharyngitis (5% vs 4%), irritability (5% vs 3%), and rhinorrhea (3% vs 2%).
Use in Specific Populations – Pediatric Use: The safety and effectiveness of OTIPRIO in infants below six months of age have not been established.
Full prescribing information can be found at www.OTIPRIO.com.
About Otonomy
Otonomy is a biopharmaceutical company focused on the development and commercialization of innovative therapeutics for diseases and disorders of the ear. OTIPRIO (ciprofloxacin otic suspension) is approved and marketed in the United States for use during tympanostomy tube placement surgery in pediatric patients, and has achieved positive pivotal trial results in patients with acute otitis externa. OTO-104 is a steroid in development for the treatment of Ménière’s disease and other severe balance and hearing disorders. Two Phase 3 trials in Ménière’s disease patients are underway, with results expected during the second half of 2017. OTO-311 is an NMDA receptor antagonist for the treatment of tinnitus that is in a Phase 1 clinical safety trial. Otonomy’s proprietary formulation technology utilizes a thermosensitive gel and drug microparticles to enable single dose treatment by a physician. For additional information please visit www.otonomy.com.
SOURCE: Otonomy
Post Views: 34
