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Panel divides over CMAX listing; FDA flags formulation, device and antithrombotic uncertainties
Summary
The advisory committee heard international clinical experience and industry proposals for CMAX (an ACTH 4–10 analog) but FDA raised concerns about missing impurity/aggregate data, lack of human PK and subcutaneous safety data, and metered‑dose nasal device compatibility; the committee returned an advisory majority in favor of listing.
The committee reviewed CMAX‑related bulk drug substances after public commenters described decades of intranasal use in other countries and clinicians reported clinical experience in neurological indications.
FDA reviewers said nominations used inconsistent nomenclature and that COAs in the public domain lacked critical impurity identity, aggregate and endotoxin data needed for injectable or intranasal metered‑dose products. Jing Li of the Office of Pharmaceutical Quality warned that metered nasal sprays require specific device‑formulation compatibility testing and spray performance evaluation.
Mary Anne San Antonio, a clinical reviewer, also flagged a possible antithrombotic signal in the literature and noted there are no human pharmacokinetic studies for CMAX by the proposed routes. "There is insufficient clinical information to characterize the clinical safety profile of CMAX via the intranasal route of administration," she told the committee.
Supporters pointed to Russian registration, published clinical cohorts and real‑world dispensing data. With a reported advisory vote of 8 yes, 5 no, and 1 abstention, the committee expressed a majority preference to add CMAX free base and acetate to the bulks list, while many members asked FDA to condition any listing on clear supply‑chain and device standards and to solicit additional translated evidence.
