Zosano Pharma Receives Complete Response Letter from FDA for Qtrypta™
--FDA feedback consistent with FDA’s preliminary communication in September--
--Company requesting meeting with FDA to discuss next steps required to resubmit the 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
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
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
Chief Financial Officer
Source: Zosano Pharma Corporation