Zosano Pharma announces publication of 'positive' Phase 1 data of Zolmitriptan
Zosano Pharma announced that Future Medicine's Pain Management Journal had published the company's positive results from a Phase 1, single center, open label, ascending-dose trial demonstrating the rapid and reproducible delivery of M207, the formulation of zolmitriptan using ADAM technology. The pharmacokinetics of zolmitriptan delivery using this technology was evaluated in 20 healthy volunteers in a phase 1 trial and median Tmax of M207 was shown to be similar to subcutaneous sumatriptan. Relative to oral zolmitriptan, absorption was substantially faster, with higher exposure in the first 2 hours when using M207. Most adverse events were consistent with those seen in previous triptan trials and no serious adverse events were observed. Application site reactions evaluated 30 minutes after application were generally mild and resolved within 24 hours. This study also demonstrated the feasibility of loading up to 3.8mg of zolmitriptan on the single array while maintaining the pharmacokinetic advantage described.