FDA Issues CRL for Grace Therapeutics’ GTx-104 Citing CMC and Toxicology Gaps
FDA issued a Complete Response Letter for Grace Therapeutics' NDA of GTx-104, citing CMC packaging leachables, nonclinical toxicology assessments, and manufacturing deficiencies. The company plans a Type A meeting with FDA to clarify requirements and resubmit the application addressing these items.
1. FDA Issues Complete Response Letter
The FDA has issued a Complete Response Letter for Grace Therapeutics’ New Drug Application for GTx-104, identifying outstanding items in the Chemistry, Manufacturing, and Controls (CMC) section related to leachables in product packaging and deficiencies at the contract manufacturing organization, as well as gaps in nonclinical toxicology risk assessments.
2. Planned Resubmission Strategy
Grace Therapeutics intends to request a Type A meeting with the FDA to discuss the cited CMC and nonclinical issues, clarify the path forward and timelines, and resubmit the NDA once the outstanding items—leachables data, toxicology assessments and manufacturing processes—are fully addressed.
3. GTx-104 Clinical Overview
GTx-104 is an injectable nimodipine formulation for aSAH patients, showing in the STRIVE-ON trial a 19% reduction in clinically significant hypotension episodes versus oral nimodipine, higher relative dose intensity (54% vs. 8% ≥95% RDI), and 29% more favorable 90-day functional outcomes, with comparable safety profiles.