FDA to discuss novel treatment for cough, upper respiratory allergies

Charleston Laboratories announced that the FDA will discuss its proposed investigational drug as novel treatment for cough relief and other symptoms associated with upper respiratory allergies or a common cold, according to a press release.

The FDA Division of Pulmonary, Allergy and Rheumatology Products has granted a Type B pre-investigational new drug application meeting for CL-AT-313, the release stated. The specialty pharmaceutical company also has submitted an investigational new drug application for the development of CL-H1T as novel therapy for migraine pain and migraine-induced nausea or vomiting.

“Our successfully completed phase 3 study with our lead asset CL-108 [a hydrocodone combination product for treating moderate to severe acute pain and the reduction of opioid-induced nausea and vomiting) combined with the clinical developments around CL-H1T and CL-AT-313 show Charleston’s core strengths and abilities to leverage our rich pipeline of products,” Paul Bosse, president and chief executive officer, said in the release. “We will continue to aggressively diversify our pipeline with our sights on defined milestones that benefit both patients and our stakeholders.”