Zosano Pharma (NASDAQ:ZSAN) has begun enrolling cluster headache patients in its Phase 2/3 study evaluating C213 for the acute treatment of cluster headache.
C213 consists of the same formulation of zolmitriptan as the company’s lead candidate for the treatment of migraines, Qtrypta, and is delivered via Zosano’s adhesive dermally applied microarray, or ADAM, patch technology.
The study will enroll some 120 adults who suffer from cluster headache. Its co-primary endpoints are the proportion of patients who achieve pain relief at 15 minutes and the proportion of patients whose pain relief is sustained from 15-to-60 minutes.
“This population suffers from excruciating and debilitating pain and has limited effective treatment options with no new FDA-approved drugs for the acute treatment of cluster headache since the 1990s,” Dr. Don Kellerman, VP clinical development and medical affairs, said in a statement.
“We are excited that the clinically significant pain freedom and relief observed in our migraine trial will potentially also be demonstrated in the cluster headache clinical trial,” he added.
