Acura and partner align with FDA on one more PK study for LTX-03; no lower overdose claim

ACURA PHARMACEUTICALS, INC

Second FDA meeting on LTX-03 (hydrocodone/acetaminophen) on May 15, 2025; one additional PK study (AP-LTX-310) planned.
Study will compare single tablet dose vs. FDA Reference Standard in fed/fasted state; requires new clinical supplies.
FDA amenable to labeling unique PK but says lower overdose risk claim not warranted by PK data alone.
Lower 5/325mg and 7.5/325mg strengths need a scientific plan; company evaluating timing for NDA or post-approval.
No assurance of NDA approval or final label; LIMITx technology shows non-linear Cmax reduction up to 30% in prior study.

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