Otonomy, Inc., a biopharmaceutical company focused on the development and commercialization of innovative therapeutics for diseases and disorders of the ear, announced that its Supplemental New Drug Application (sNDA) for the approval of Otiprio as a treatment of acute otitis externa (AOE) has been accepted for filing by the US Food and Drug Administration (FDA) and been assigned a Prescription Drug User Fee Act (PDUFA) action date of March 2, 2018. The acceptance of the sNDA indicates that the application is sufficiently complete to permit a substantive review by the FDA.
“We are pleased to receive confirmation of the sNDA filing acceptance and PDUFA action date which is consistent with our expectations and previous investor communications,” said David A. Weber, Ph.D., president and CEO of Otonomy. “If approved within the standard review period, Otonomy anticipates a commercial launch of Otiprio for this second indication, which is primarily treated by physicians in the office setting, prior to the peak summer season for AOE.”
The sNDA is supported by positive results from a pivotal phase 3 clinical trial of Otiprio in 262 paediatric and adult patients with AOE. This single administration trial of Otiprio met its primary endpoint showing a statistically significant increase in clinical cure rate compared to sham (no treatment) at Day 8 (p<0.001). Otiprio also demonstrated a statistically significant increase in clinical cure rate compared to sham 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 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.
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).
Us fda accepts, otonomy's otiprio snda filing, acute otitis externa
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