ACCENTIA'S IND FOR SINUNASE ON TRACK

Accentia Biopharmaceuticals has received confirmation recently from the FDA that its investigational new drug (IND) application for the company's proprietary drug SinuNase will remain under the direction of the Special Pathogens and Transplant Products (SPTP) section of the Centers for Drug Evaluation and Research (CEDR) of the FDA.

Accentia proposes to move forward with its first Phase III study on recurrent post-surgical chronic sinusitis patients, and would like to include in its confirmatory Phase III study additional patients who suffer from moderate to severe chronic sinusitis but have not had surgery, in order to seek an expanded label indication when the drug launches.