Zosano Receives Conditional FDA Acceptance of Proposed Brand Name Qtrypta™ for M207
December 12 2018 - 8:30AM
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.
Forward-Looking StatementsThis 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.
Zosano Contact: Greg Kitchener Chief Financial
Officer 510-745-1200
Media Contact:Sara ZelkovicLifeSci Public
Relationssara@lifescipublicrelations.com646-876-4933
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