Zosano Enrol First Subject for Pivotal Clinical Efficacy Trial for ZP-Triptan Patch Program to Treat Migraine Attacks

Zosano Pharma Corporation is a clinical stage pharmaceutical company that specializes in dermal delivery of therapeutic drugs. The company recently announced that they started the enrollment of the first subject for the pivotal efficacy trial of its candidate patch treatment ZP-Triptan for the treatment of migraine.  Zp-Triptan is a zolmitriptan-coated proprietary microneedle patch which is applied on subject’s upper arm.  It will be the point of entry of the drug zolmitriptan which is used to treat migraine attack.

The efficacy pivotal study is a randomized, placebo-controlled, and multi-center trial comparing three dose of ZP-Triptan namely 1.0 mg, 1.9 mg. and 3.8 mg. to the placebo to treat a single attack of migraine.  It is expected that three hundred and sixty subjects will be enrolled in roughly 35 centers in the United States.

Based from the discussions made by the company with FDA, they agreed to comply with the October 2014 Draft Guidance of FDA entitled “Migraine: Developing Drugs for Acute Treatment”.  The co-primary end goal of the study are first, pain freedom at 2 hours following the application of the patch and second, freedom from the most bothersome symptom of the subject at 2 hours of post-dosing.

Konstantinos Alataris, Ph.D., Chief Executive Officer and President of Zosano’s, said that the initiation of the pivotal efficacy trial of ZP-Triptan for the treatment of migraine holds an important milestone as the company  transition into their anticipated final stage of drug development. Alataris also reiterated that they are expected to report the results of the pivotal efficacy data on the first quarter of 2017. The CEO also added that the ZP-Triptan demonstrate a fast absorption based from its pharmacokinetic profile.  This effect was observed during the Phase 1 of the trial which translates that the patch provides rapid relief of pain for migraine sufferers.

If the company will be able to establish that ZP-Triptan has an effective and rapid pain relief profile through dermal patch delivery, they will be able to attract millions of patient to try this solution.  This will be accepted by many because it is simple and there is no need for injection.

As discussed, FDA noted that a single and positive result of the pivotal efficacy study, in addition to safety study will be enough to be granted an approval. Zosano plans to complete the safety profile of the study after completing the pivotal efficacy trial study.

About Zosano Pharmaceuticals

Zosano Pharma has been developing transdermal microneedle patch application system to deliver various drug formulations for the treatment of different indications. The company’s proprietary microneedle patch system provides consistent and rapid drug delivery with improved and ease of use.  Their patch system has room-temperature stability which is often not available in injection or oral formulations.

The microneedle patch system of Zosano’s Pharma has been proven to be effective in delivering numerous medications to treat various indications.  The system has a commercially attractive market considering that it can be used in different indications and most of the conditions are common worldwide.  The drug has been tested for over 400 patients and more than 30,000 patches were used in Phase 1 and Phase 2 human clinical studies.

Migraine No More

Migraine sufferers will take benefit from this drug considering that there is no need to take injections or oral formulations. If Zosano will be able to prove that the dermal patch system is effective in treating migraine, then the drug will have a very good potential in the market.

 

Leave a Reply