Heron Therapeutics Inc. (NASDAQ:HRTX) has announced the resubmission of the New Drug Application for HTX-011 to the US FDA. HTX-011 is an experimental agent the company is developing for postoperative pain management.
Heron resubmits NDA with additional information on issues raised in CRL
The company resubmitted the NDA for HTX-011 based on the results and final minutes of a Type A End-of-Review meeting with the agency in September. The review was conducted to get clarity on the needed information to address the FDA’s Complete Response Letter (CRL) of June 2020. The FDA had indicated in the letter that it was unable to approve the NDA in its current status because there was a need for more clinical information.
In the CRL four non-clinical issues needed to be addressed. Three of the issues were related to confirmation of excipients exposure in preclinical reproductive toxicology trials while the fourth issue is related to changing the manufacturing releases specification of the permitted impurity level based on toxicology coverage in animals. The company generated data indicating that that peak excipient plasma levels in toxicology trials were>50-to >200 higher compared to patients that received animal studies.
Heron agreed to a manufacturing specification change for HTX-011
At the September meeting, the agency agreed to the manufacturing specification change the company proposed to address their concerns. The agency indicated during the meeting that submission will be categorized as Class 2 resubmission meaning that the FDA could take up to 6 months to reviewing the additional information the company provided in the NDA resubmission.
Heron CEO Barry Quart said that they are delighted to have resubmitted the HTX-011 NDA which they are optimistic will address the CRL based on the FDA’s guidance. He added that in the resubmission the company offered compelling evidence in response to the issues the FDA identified in the CRL which could offer a basis for HTX-011 NDA’s approval. Quart said that the company is committed to delivering HTX-011 to patients and they will continue cooperating with the FDA to meet this goal.