Chronic rhinosinusitis (CRS) represents an important underserved medical need and a large market opportunity.
- CRS may affect as many as 30 million adults in the United States, half of whom have been diagnosed
- The US healthcare system has been estimated to spend $60 billion annually in direct costs treating patients with CRS and its associated symptoms
- Roughly 7 million people in the United States alone are affected enough that they have undergone nasal/sinus surgery to try to reduce their symptoms, with approximately 500,000 surgeries performed every year
- Up to 10 million chronic sinusitis patients develop nasal polyps, which are benign growths in the lining of the nose that can block nasal passages and interfere with breathing
- CRS results in over 18 million office visits per year in the United States
- Nearly half (47%) of visits for CRS result in a prescription for antibiotics
Few Available Options
There are no currently approved medications in the United States or Europe for the treatment of chronic sinusitis, and only one is approved for the treatment of nasal polyps. For both conditions, new treatments in development other than OPN-375 from Optinose® include expensive monoclonal antibody injections that affect the entire body.
Nasal polyp sufferers use multiple acute and chronic prescription and nonprescription treatment modalities, including:
- Nasal, oral, and injected steroids
- Antibiotics and antifungal treatments
- Topical and oral decongestants
- Locally compounded steroid-containing lavages
- Saline irrigation such as with a Neti pot
While all of these treatments exist, they are not necessarily perceived as highly effective by patients. In fact, 80% of CRS patients are frustrated with the level of symptom relief provided by their current treatments.
Treatments for CRS which are considered effective, such as sinus surgery, aren’t typically curative, and the procedures are expensive.
- Nasal polyp regrowth after surgery occurs in as many as 60% of cases within 4 years
- Many patients continue to require short- and long-term maintenance with steroids after surgery
- The estimated cost of sinus surgery ranges from $8,500-$16,000
- Intranasal steroids are still required in most patients following surgery
These treatments are often burdensome, complex, time-consuming, and expensive. Despite the fact that almost all patients use chronic medication, many do not achieve satisfactory relief. Even patients who progress to surgery may have limited success, sometimes undergoing multiple procedures and usually continuing to use medication after the procedure.
CRS is a serious disease, and although rarely fatal, it causes severe morbidity as assessed by harm to quality of life. The quality of life for patients suffering from CRS has been measured and in multiple domains is similar to or worse than that of patients with other serious diseases, such as congestive heart failure, chronic obstructive pulmonary disease, angina, and diabetes. Other symptoms of CRS include chronic sleep problems, headaches, fatigue, frequent episodes of acute rhinosinusitis, and mood disorders.
- Caulley L, Thavorn K, Rudmik L, et al. Direct costs of adult chronic rhinosinusitis by using 4 methods of estimation: results of the US Medical Expenditure Panel Survery. J Allergy Clin Immunol. 2015;136(6):1517-1522.
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- Data on file. Optinose US, Inc.
- Battacharrya N. Symptom outcomes after endoscopic sinus surgery for chronic rhinosinusitis. Arch Otolaryngol Head Neck Surg. 2004;130:329-333.