Sunovion's inhaled steroid for allergies looks good in Ph3 amid FDA review

While the FDA reviews its application for approval of the experimental drug, Sunovion Pharmaceuticals revealed upbeat data from a major Phase III trial of its ciclesonide nasal aerosol against allergic rhinitis. The treatment, a corticosteroid delivered with a hydrofluoroalkane (HFA) propellant, gave patients "statistically significant" relief from nasal symptoms after 6 weeks of treatment in the 6-month study, the company said in a release.

Marlborough, MA-based Sunovion--a unit of Japan's Dainippon Sumitomo that develops assets that Dainippon picked up in its $2.6 billion buyout of Sepracor--said that both the 74 mcg and 148 mcg doses provided significant improvements to symptoms and were well tolerated among patients who took the treatment in the 1,111 patient trial. After 6 months of treatment both doses of the treatment were well tolerated, the Worcester Telegram & Gazette reported, and nose bleeds and headaches were the most common side effects.

The data were presented at the annual American College of Allergy, Asthma & Immunology meeting in Boston.

The delivery tech behind the product enables the corticosteroid to be delivered into the a patient's nose as a dry mist, cutting down on "back-of-the-throat run-off and run-out out of the nose that can occur with aqueous-based corticosteroids," the firm reported. The FDA accepted the group's new drug application for the product in June, meaning that U.S. regulators have agreed to review the application and decide whether to approve the drug.

"Perennial allergic rhinitis has a significant effect on millions of people nationwide and researchers and industry are committed to developing new and innovative treatment options to address a wide variety of patient needs," Dr. William Berger, a clinical professor in pediatrics at University of California, Irvine, and the lead investigator of the study, said in a statement. "We are encouraged by these findings from this Phase III study in PAR patients investigating ciclesonide nasal aerosol in an HFA propellant."

- here's the release
- see the Worcester Telegram's story