You are here
Zosano Receives Conditional FDA Acceptance of Proposed Brand Name Qtrypta™ for M207
FREMONT, Calif., Dec. 12, 2018 (GLOBE NEWSWIRE) -- Zosano Pharma Corporation (NASDAQ:ZSAN) (“Zosano” or the “Company”), a clinical-stage biopharmaceutical company, today announced that the U.S. Food and Drug Administration (FDA) has conditionally accepted the proposed brand name Qtrypta™ for M207, the Company’s investigational drug for treatment of migraine. A request for proprietary name review and final approval for Qtrypta will be included when Zosano submits a New Drug Application (NDA) for M207.
The name Qtrypta (pronounced "kew-trip-tah") was developed in compliance with the FDA's Guidance for Industry, Contents of a Complete Submission for the Evaluation of Proprietary Names. The proprietary name development program included research with physicians and pharmacists, and FDA’s conditional approval validated Qtrypta is a proprietary name that is consistent with the FDA's goal of preventing medication errors and potential harm to the public by ensuring that only appropriate proprietary names are approved for use. Final approval of the Qtrypta brand name is conditional on FDA approval of the product candidate, M207.
“We are pleased that the FDA has conditionally accepted the name Qtrypta for our lead product candidate,” said John Walker, chairman and chief executive officer of Zosano. “This meaningful step forward aligns with our continued clinical progress as well as preparation for the commercialization of Qtrypta, if approved. The Company has reached a number of milestones in 2018 and we are looking forward to the coming year in which we expect to file an NDA for Qtrypta.”
Qtrypta is a novel formulation of zolmitriptan, administered through Zosano’s proprietary Adhesive Dermally-Applied Microneedle System (ADAM™) technology.
About Qtrypta (M207)
Qtrypta is Zosano’s proprietary formulation of zolmitriptan delivered utilizing its proprietary ADAM technology. Zosano's ADAM technology consists of titanium microneedles coated with drug, and in the case of Qtrypta, its formulation of zolmitriptan. The drug-coated microneedles penetrate into the epidermis and dermis, where the investigational drug is dissolved and enters into the bloodstream. In February 2017, the Company announced statistically significant results from the ZOTRIP pivotal study, in which the 3.8mg dose of Qtrypta met both co-primary endpoints, achieving pain freedom and most bothersome symptom freedom at 2 hours. In November 2017, the Company announced the initiation of its long-term safety study evaluating Qtrypta and expects to file an NDA for Qtrypta in the fourth quarter of 2019.
This press release contains forward-looking statements regarding the expected timing of an NDA for Qtrypta 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," "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, without limitation, risks and uncertainties 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 quarterly report on Form 10-Q. 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
LifeSci Public Relations