Zosano Announces Completion of the Final Milestone in the Long-Term Safety Study of Qtrypta™ for the Acute Treatment of Migraine Disease
- Long-term one-year dosing reaffirmed well-tolerated safety profile
- Qtrypta showed robust and rapid relief of migraine pain, an effect that was consistent throughout the chronic treatment period
- NDA submission expected in Q4 2019 for the first intracutaneous delivery system
“Successfully concluding our Phase 3 program for Qtrypta and observing consistent long-term safety and efficacy results are exciting milestones for Zosano,” said
“With these additional data showing long-term tolerability and robust efficacy, I believe Qtrypta, if approved, will be an important and attractive treatment for my patients with migraines,” said
The Qtrypta long-term safety trial is an open-label study evaluating the safety of the 3.8 mg dose of intracutaneous zolmitriptan in adults with migraine who have historically experienced at least 2 migraine attacks per month. There were no maximum treatment limits. The study evaluated over 150 adults with migraine disease for six months, and more than 50 patients for a year at 31 sites in the U.S.
Of more than 5,800 migraines treated, investigators reported 832 adverse events, of which 298 were reported as application site reactions and 161 were reported as triptan related adverse events.
Observational efficacy parameters continued to demonstrate a rate of pain freedom at two hours following patch application of approximately 44% and most bothersome symptom freedom of approximately 68%, while pain relief at two hours was reported at 81% of migraine attacks treated.
About Qtrypta (M207)
Qtrypta is Zosano’s proprietary formulation of zolmitriptan delivered utilizing its proprietary technology. Zosano's intracutaneous drug delivery technology consists of titanium microneedles coated with drug, and in the case of Qtrypta, its formulation of zolmitriptan. The drug-coated microneedles penetrate through the epidermis, where the investigational drug is dissolved and enters the bloodstream. In
This press release contains forward-looking statements regarding the expected timing of a New Drug Application for Qtrypta (M207) and other future events and expectations. Readers are urged to consider statements that include the words "may," "will," "would," "could," "should," "might," "believes," "estimates," "projects," "potential," "expects," "plans," "anticipates," "intends," "continues," "forecast," "designed," "goal," "unaudited," "approximately" or the negative of those words or other comparable words to be uncertain and forward-looking. These statements are subject to risks and uncertainties that are difficult to predict, and actual outcomes may differ materially. These include risks and uncertainties, without limitation, associated with the process of discovering, developing and commercializing products that are safe and effective for use as human therapeutics, risks inherent in the effort to build a business around such products and other risks and uncertainties described under the heading "Risk Factors" in the Company's most recent annual report on Form 10-K. Although Zosano believes that the expectations reflected in these forward-looking statements are reasonable, we cannot in any way guarantee that the future results, level of activity, performance or events and circumstances reflected in forward-looking statements will be achieved or occur. All forward-looking statements are based on information currently available to Zosano and Zosano assumes no obligation to update any such forward-looking statements.
Chief Financial Officer
Source: Zosano Pharma Corporation