The US FDA Accepts Zosano Pharma Corp (NASDAQ:ZSAN)’s NDA For Qtrypta To Treat Migraine

Zosano Pharma Corp (NASDAQ:ZSAN) received the US FDA’s approval for NDA submission for its innovative drug – Qtrypta to cure migraine. If its Qtrypa could pass the clinical trials, the company would join a few companies in meeting significant unmet medical needs.

On approval, Qtrypta would serve as a valuable medicine for patients who cannot consume medicines orally because of challenging medical conditions, to cure migraine-related with nausea.

Excellent efficacy and tolerability

In a virtual annual scientific conference presentation at AMS (American Medical Society), Zosano’s Qtrypta showed excellent tolerability and efficacy in a long-term study conducted on 6,000 migraine episodes.

Significant unmet needs exist to cure migraine

According to market research involving high volume payors and physicians that comprise 100 physician specialists, 79 physicians said considerable unmet needs exist for treating patients with migraine. Around 70% of the physicians recommend non-oral tryptan to provide quick and complete relief from pain.

Delivery of Qtrypta

The proprietary investigational formulae of zolmitriptan – Qtrypta is administered using a transdermal microneedle system to the patients to treat migraines. Titanium microneedles in this system are coated with Qtrypta to provide an effective cure by penetrating the stratum corneum.

In a study conducted in February 2017, 3.8 mg of Qtrypta achieved both the co-end primary points and provided effective treatment for migraine-related pain.

In the US, 12% of the population suffers from migraines, a highly prevalent neurological disease. Patients who are no treated for migraine, suffer from a significant disability. The lost productivity because of highly prevalent migraine in the US is around $36 billion a year. Zosano intends to cash in on this unmet need to boost revenues and provide effective treatment for migraines.

To commercialize and introduce Qtrypta on receipt of approval from the FDA, Zosano entered a pact with EVERSANA. The deal is valued at $250 million for 5 years. Zosano, Steven Lo, said Qtrypta holds great potential to cure patients suffering from debilitating migraine impact.

Narrows down the loss to $7.9 million

Zosano narrowed its loss in Q2 2020 to $7.9 million from $9.4 million in Q2 2019. The company also reduced R & D expenses in Q2 2020 to $4.9 million because of clinical trials’ lower costs. Its cash rose to $10.5 million in Q2 2020.