Sara Louise Joe
There's a Pharmacist in the House LLC, USA
Title: IDS-iontophoretic delivery of Sumatriptan-trials, tribulations but little triumph: A perspective
Biography
Biography: Sara Louise Joe
Abstract
With a dear health care provider (DHCP) letter, dated June 10, 2016, Teva Pharmaceuticals temporarily suspended the sale, marketing and distribution of ZECUITY® (Sumatriptan Iontophoretic Transdermal System) due to post-marketing reports of application site reactions described as “burn” and/or “scar” in patients treated with ZECUITY®. The first and only FDA-approved migraine patch’s September 2015 release, indicated for the acute treatment of migraine headaches with or without aura had represented what was thought to be a game-changing treatment option for millions of migraine patients, especially those with migraine-related nausea (MRN). Accordingly, a beginning-to-end study was launched in the interest of preventing reoccurrence, analyzing root causes and providing corrective tools and solutions. The science of iontophoretic delivery systems, the technology of transdermal route of administrations, and methods of adverse event reporting and post-marketing surveillance were scrutinized.