Zosano Pharma Receives Complete Response Letter from FDA for Qtrypta™
October 21 2020 - 8:30AM
Zosano Pharma Corporation (NASDAQ:ZSAN), a clinical-stage
biopharmaceutical company, announced today that it has received a
complete response letter (CRL) from the U.S. Food and Drug
Administration (FDA) in connection with the Qtrypta™ (zolmitriptan
transdermal microneedle system) 505(b)(2) New Drug Application
(NDA).
The CRL cited inconsistent zolmitriptan exposure levels observed
across clinical pharmacology studies, which had been previously
identified in the FDA’s discipline review letter in September.
Specifically, the CRL noted differences in zolmitriptan exposures
observed between subjects receiving different lots of Qtrypta in
the company’s trials and inadequate pharmacokinetic bridging
between the lots that made interpretation of some safety data
unclear. The CRL referenced unexpected high plasma concentrations
of zolmitriptan observed in five study subjects enrolled in the
company’s pharmacokinetic studies. The FDA recommended that the
company conduct a repeat bioequivalence study between three of the
lots used during development. The NDA included data on a total of
774 subjects across 5 trials who were administered or dosed with
Qtrypta.
The CRL noted that additional product quality validation data,
which were planned to be submitted following approval, if received,
were required to be submitted with the application. In addition,
the CRL mentioned that due to U.S. Government and/or Agency-wide
restrictions on travel, inspections of Zosano’s contract
manufacturing facilities were not able to be conducted but would be
required before the application may be approved.
Zosano will request a Type A meeting with the FDA to discuss
strategies to address the FDA’s comments.
“We are working diligently to address the deficiencies
identified by the FDA and look forward to the possibility of
resubmitting our NDA,” said Steven Lo, president and chief
executive of Zosano. “We expect that the Type A meeting with the
FDA will provide clarity on the next steps for the program, which
we will communicate once solidified. There are thousands of people
suffering from migraine attacks that are not adequately addressed
with available drugs, and we continue to believe that Qtrypta, if
approved, could offer a much-needed new therapy for these
patients.”
About Zosano PharmaZosano Pharma Corporation is
a clinical-stage biopharmaceutical company focused on developing
products where rapid administration of approved molecules with
established safety and efficacy profiles may provide substantial
benefit to patients, in markets where patients remain underserved
by existing therapies. The company’s transdermal microneedle system
technology consists of titanium microneedles coated with drug that
are designed to enable rapid systemic administration of
therapeutics to patients. Zosano’s lead product candidate is
Qtrypta™ (M207), which is a proprietary formulation of zolmitriptan
designed to be delivered via its transdermal microneedle system
technology, as an acute treatment for migraine. Learn more at
www.zosanopharma.com or connect through LinkedIn and Twitter.
Forward-Looking StatementsThis press release
contains forward-looking statements. All statements other than
statements of historical facts contained herein are forward-looking
statements reflecting the current beliefs and expectations of
management made pursuant to the safe harbor provisions of the
Private Securities Litigation Reform Act of 1995, including, but
not limited to, the company’s plan to request a Type A meeting with
the FDA to discuss strategies to address the FDA’s comments in the
CRL and the company’s expectations with respect to the meeting with
the FDA. Such forward-looking statements involve known and unknown
risks, uncertainties, and other important factors that may cause
the company’s actual results, performance, or achievements to be
materially different from any future results, performance, or
achievements expressed or implied by the forward-looking
statements. For a further description of the risks and
uncertainties that could cause actual results to differ from those
expressed in these forward-looking statements, as well as risks
relating to the company’s business in general, see the most recent
Annual Report on Form 10-K and Quarterly Reports on Form 10-Q filed
with the Securities and Exchange Commission. The company does not
plan to publicly update or revise any forward-looking statements
contained in this press release, whether as a result of any new
information, future events, changed circumstances or otherwise,
except as required by law.
Zosano Contacts:Christine MatthewsChief
Financial Officer 510-745-1200
Zosano PR:Sylvia Wheeler or Alexandra
Santosswheeler@wheelhouselsa.com or
asantos@wheelhouselsa.com
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