Zosano Pharma Files IND for a Phase 2/3 Clinical Study in Cluster Headache

Zosano Pharma (NASDAQ:ZSAN) has announced it has filed an investigational new drug application to the US Food and Drug Administration (FDA) for a Phase 2/23 clinical trial of C213 in patients with cluster headaches.

As quoted in the press release:

C213, for the treatment of cluster headache, consists of the company’s investigational proprietary formulation of zolmitriptan delivered utilizing its proprietary ADAM technology, which consists of titanium microneedles coated with drug, and is the same formulation as Qtrypta, for the acute treatment of migraine.

“There is a substantial need for new treatment options for people suffering from cluster headache, which produces an excruciating pain that has been described as one of the most severe types of pain known to medical science,” said Don Kellerman, Vice President of Clinical Development and Medical Affairs. “The challenge with treating this debilitating condition is that the attacks are relatively short-lasting and quick onset medications are required in order to provide meaningful benefit to patients. Based on the pharmacokinetic profile and onset of pain relief seen in our clinical trials with Qtrypta for Migraines, we believe C213 has the potential to be a transformational therapy for patients with cluster headaches.”

Click here to read the full press release.