BACTERIAL SINUSITIS:

Bacterial sinusitis involves inflammation of the mucous membrane lining of the sinuses, and is caused by a bacterial infection.

Bacterial sinusitis often follows a viral infection, such as a cold or the flu. Viral infections can cause the mucosal lining of the sinuses to swell. In healthy sinuses, mucus drains into the nasal cavity via small holes, known as ostia. Swelling of the mucus membranes in the nose or sinus cavities can block these holes, preventing mucus from draining out of the sinuses. Bacteria colonize the undrained mucus, which can lead to bacterial sinusitis.

Sinusitis affects an estimated 32 million adults in the United States annually . It is one of the most common diseases seen in primary care practice, with 11.7 million office visits and 1.2 million hospital outpatient unit visits in 2000 and direct annual costs in excess of $2.4 billion

AOSI-04

Aodh Lifesciences developed antibiotic nasal spray to attenuate bacterial sinusitis. Targeted delivery increase the efficiency and reduce the adverse effects.

Nasal sprays are also gaining popularity as an alternative approach to chronic sinusitis symptom relief, and several randomized controlled trials (RCTs) have demonstrated both objective and subjective efficacy of this treatment for sinonasal disease.

Regulatory Pathway:

  • 505(b)(2)
  • Limited Population Pathway for Antibacterial and Antifungal Drugs