Xhance Approved for Nasal Polyps
September 18, 2017 – The U.S. FDA has approved Xhance™ (fluticasone propionate) nasal spray, manufactured by OptiNose, to treat congestion and inflammation caused by nasal polyps in adults at least 18 years of age. An estimated 10 million Americans live with nasal polyps, which can lead to congestion, sinusitis, reduced sense of smell, secondary infections, and headaches.
Fluticasone propionate, the active ingredient in Xhance, is an inhaled corticosteroid. OptiNose’s proprietary Exhalation Delivery System is designed to administer targeted doses of this steroid deep inside the nasal area. To use the device, patients blow into a mouthpiece while simultaneously pressing down on a pump to deliver the spray through a nosepiece. Each pump delivers 93mcg of fluticasone inside the nasal cavity. Recommended dosing is one spray into each nostril twice per day. In some cases, the dosing may be increased to two sprays per nostril twice per day. Full effects may not be apparent until after 16 weeks of regular use. Possible side effects include bleeding, fungal infections, or sores inside the nose.
Each bottle of Xhance will contain 120 sprays, and will be packaged with the Exhalation Delivery System device. Distribution will begin in the first quarter of 2018.
Adverse reactions or quality problems experienced with the use of a recalled product may be reported to the FDA’s MedWatch Adverse Event Reporting Program either online, by U.S. mail or by fax.
- Complete and submit the report Online: www.fda.gov/medwatch/report.htm
- U.S. Mail or Fax: Download form www.fda.gov/MedWatch/getforms.htm or call 1-800-332-1088 to request a reporting form, then complete and return to the address on the pre-addressed form, or submit by fax to 1-800-FDA-0178
Actual drug patent expiration dates and availability of new medications are subject to change due to patent litigation, settlement agreements, additional patents, exclusivities, and final FDA approval. Distribution and availability of new medications at pharmacies may not occur immediately following FDA approval. Patients are advised to speak with their healthcare professional or pharmacist regarding appropriateness as well as actual availability.
*This is provided for information only. The reference to any medication above does not mean the medication is covered by your plan.