Zosano Pharma Receives Complete Response Letter from FDA for Qtrypta™
Zosano Pharma Corporation (NASDAQ:ZSAN) has received a complete response letter (CRL) from the FDA regarding its Qtrypta™ New Drug Application. The CRL highlighted inconsistent exposure levels of zolmitriptan across clinical studies and suggested a repeat bioequivalence study. Additionally, it noted that a lack of product quality validation data was a concern, and inspections of the company's manufacturing facilities are required for approval. Zosano plans to request a Type A meeting with the FDA to discuss addressing these issues.
- Company is actively engaging with the FDA for a Type A meeting to resolve issues.
- Qtrypta targets a critical need for effective migraine treatment.
- CRL cited inconsistent zolmitriptan exposure levels across clinical trials.
- Additional product quality data required for NDA resubmission.
- Inspections of contract manufacturing facilities not yet conducted, delaying approval.
--FDA feedback consistent with FDA’s preliminary communication in September--
--Company requesting meeting with FDA to discuss next steps required to resubmit the NDA--
FREMONT, Calif., Oct. 21, 2020 (GLOBE NEWSWIRE) -- 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 Pharma
Zosano 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 Statements
This 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 Matthews
Chief Financial Officer
510-745-1200
Zosano PR:
Sylvia Wheeler or Alexandra Santos
swheeler@wheelhouselsa.com or asantos@wheelhouselsa.com
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