Migraine treatment ‘on track’ for NDA after site qualification

By Maggie Lynch contact

- Last updated on GMT

(Image: Getty/peopleimages)
(Image: Getty/peopleimages)

Related tags: NDA, Migraine, Investigational new drug, Clinical supply, Manufacturing

Zosano completes site qualification batches for its subcutaneous investigational migraine treatment and readies itself for NDA submission by the end of year.

Clinical-stage biopharma company, Zosano announced it has completed manufacturing of site qualification batches for its investigational migraine treatment, Qtrypta (zolmitriptan).

The batches completed at the manufacturing site demonstrate the reproducibility of the manufacturing process, which will be included in the company’s planned submission of a new drug application (NDA) for Qtrypta, currently in late-stage development.

Hayley Lewis, SVP of operations at Zosano, told us, “With the completion of our long-term safety study, the transfer of our manufacturing process and the ongoing completion of requisite regulatory documentation and studies, we are on track for NDA submission by year end.”

Qtrypta is a treatment for migraines that uses the company’s proprietary formulation of the zolmitriptan delivered through adhesive dermally-applied microarray (ADAM) technology. This technology uses titanium microneedles coated in the drug that penetrate the skin and enter the bloodstream.

A spokesperson for Zosano told us that the manufacturing process for this drug and technology consists of the formation of the microneedle array, applying the drug formulation to the microneedle array, the etching of titanium foil and the production of the pad it is anchored to.

The spokesperson explained that the ADAM technology used in this drug has potential applications in additional therapeutic areas utilizing other active compounds. However, they added that Zosano will focus on its use in Qtrypta, which has demonstrated statistically significant data on co-primary endpoints and provided pain relief to 80% of patients within two hours of application.

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