Drug Delivery
options that are non-invasive, fast acting and bypass the gastrointestinal tract. In recent years, innovators in the field have been working to pro- vide new options that address these unmet treat- ment needs. In 2013, the United States Food and Drug
Administration (FDA) approved Zecuity®, a sin- gle-use migraine patch that delivers sumatriptan through a mild-powered electrical current. Developers of Zecuity recognised that sumatriptan is an effective, already-approved drug for the treatment of migraine and worked to improve delivery of the drug to patients suffering from migraine to potentially provide faster symptom relief. To do this they employed the use of an ion- tophoretic transdermal system to deliver suma- triptan directly to the bloodstream, bypassing the gastrointestinal tract. However, in 2016, less than a year after Zecuity launched, the FDA issued a safety warning regarding the risk of burns and possible scarring due to the patch. Despite this set- back, development of TDD for the treatment of migraine has not stalled. Zosano Pharma is currently developing
Qtrypta™ (formerly M207), its proprietary formu- lation of zolmitriptan delivered utilising its Adhesive Dermally Applied Microneedle™ (ADAM) technology. Zolmitriptan is an effective FDA-approved treatment for migraine but is only available as an oral tablet and nasal spray, and not as an injectable. Innovators at Zosano recognised that there is room for improvement in the delivery of this migraine drug to potentially provide faster relief to patients. The company’s TDD system consists of a titani-
um microneedle array attached to an adhesive patch seated in a retainer ring, which is applied with an applicator. When the patch is applied to the skin, microneedles coated with zolmitriptan physically break the stratum corneum and pene- trate the epidermis/dermis, where the dry drug coating is dissolved by the surrounding skin inter- stitial fluid, delivering the drug directly into the bloodstream. Clinical results to date demonstrate its potential to provide positive symptom relief to patients with migraine.
Conclusion Transdermal Drug Delivery technology offers com- pelling opportunities to address a number of issues associated with commonly-used drug delivery methods. In time, it is anticipated that technological advancements in TDD will lead to improvement in quality of life for those suffering from migraine and potentially other diseases.
DDW 54 Drug Discovery World Winter 2018/19
Dr Mahmoud Ameri is the Vice-President of Research & Development at Zosano Pharma. As one of the company’s co-founders, he brings 20 years of drug delivery, preclinical and early ex-US clinical development of combination products to the company. He is responsible for research and devel- opment. Prior to Zosano, he was at Alza/J&J where he co-invented and developed the Adhesive Dermally Applied Microarray system and holds more than 20 patents and patent applications all relating to the Zosano drug delivery technology. Dr Ameri earned his PhD from the School of Pharmacy at the University of Manchester in the UK.
Hayley Lewis is the Senior Vice-President of Operations at Zosano Pharma, where she oversees the functional areas of Nonclinical, R&D, Analytical Development and QC, Operations and Engineering, Manufacturing, and Regulatory Affairs, and continues to be responsible for over- seeing all regulatory interactions with the FDA and other government agencies. She joined the compa- ny as the Vice-President of Regulatory Affairs and Quality in October 2015. Prior to joining Zosano, she spent more than 11 years in Regulatory Affairs at Depomed, Inc, a specialty pharmaceutical com- pany, where she was involved in the approval of three commercial products. Over the course of her career, she has enabled eight investigational prod- ucts to be studied in humans, five of which have advanced to completion of Phase III trials. Her pharmaceutical development experience, spanning more than 20 years, covers solid oral dosage forms and combination products, such as systemic and local inhalation products, a single-entity combina- tion injectable and transdermal systems. Ms Lewis earned her BS in Pharmaceutical Sciences from the University of Greenwich in the UK, and has attained several management diplomas from Kellogg School of Management, as well as Stanford’s Graduate School of Business.
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