FDA CRL - Ironshore Pharmaceuticals & Development, Inc.

The FDA issued a Complete Response Letter (CRL) to Ironshore Pharmaceuticals & Development, Inc. for its New Drug Application (NDA 209311) for Jornay PM (methylphenidate hydrochloride) Modified Release Capsules, submitted under section 505(b)(2) of the Federal Food, Drug, and Cosmetic Act. The application was deemed unapprovable in its current form due to significant clinical safety concerns and data deficiencies.

The primary issue was an unacceptably high rate of insomnia, observed in approximately 33% of patients treated with HLD 200 in Phase 3 studies. This rate was considerably higher than both placebo (9%) and other approved methylphenidate products (2-13%), with younger children showing even greater susceptibility. The timing of the evening dose did not mitigate this risk.

Required actions for Ironshore include conducting an additional double-blind, placebo-controlled, fixed-dose study in children aged 6 to 12 years to identify a safe and effective lower dose. A similar study in adolescents (13-17) may also be necessary. Furthermore, the company must provide an updated, comprehensive safety report detailing any changes in the safety profile, incorporating new data, and summarizing worldwide experience, as per 21 CFR 314.50(d)(5)(vi)(b). The proposed proprietary name must be resubmitted, and prescribing information updated in Structured Product Labeling (SPL) format. Ironshore has one year to submit a complete response to these deficiencies.